Data / Medical devices / United States / Ethicon Endo-Surgery, LLC
Ethicon Endo-Surgery, LLC: FDA-registered device maker in Guaynabo, PR, United States, 85 510(k) clearances
Ethicon Endo-Surgery, LLC is registered with the FDA (registration 3005075853) in Guaynabo, PR, United States. It lists 18 device types. The FDA files 85 510(k) clearances under its listings, the newest dated May 11, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005075853
- Address
- 475 Calle C, Guaynabo, PR, United States, 00969
- Owner or operator
- ETHICON ENDO-SURGERY, LLC (9071406)
- Roles
- Manufacturer for export, Specification developer
- First device listed
- October 18, 2005
- Registered through
- 2026
- Brand names listed
- 12-L 12MM Endoscopic ROTATING MULTIPLE CLIP APLLIER, ADVANT, CONTOUR, CONTOUR TRANSTAR, Circular Sizer, DUALTO Energy System, ECHELON, ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 11, 2026 | K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 9, 2026 | K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | OXC | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| December 17, 2025 | K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 14, 2025 | K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 17, 2025 | K243067 | The ETHICON Total Energy System | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company) | accessdata.fda.gov |
| October 28, 2024 | K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| July 3, 2024 | K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | GAG | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| August 29, 2023 | K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | FZP | Substantially Equivalent | Ethicon Endo Surgery, LLC | accessdata.fda.gov |
| April 13, 2023 | K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 15, 2023 | K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) | GDW | Substantially Equivalent | Ethicon Endo-Surgery | accessdata.fda.gov |
| February 28, 2023 | K221790 | HARMONIC 700 Shears | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 16, 2022 | K221343 | ECHELON ENDOPATH Staple Line Reinforcement | OXC | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 8, 2022 | K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | GAG | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 21, 2021 | K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 22, 2021 | K201696 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 22, 2021 | K201066 | ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 15, 2020 | K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| July 27, 2020 | K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| June 29, 2020 | K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| June 26, 2020 | K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | FYD | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| May 11, 2020 | K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| February 28, 2020 | K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 14, 2019 | K190937 | Echelon Endopath Staple Line Reinforcement | OXC | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| February 6, 2019 | K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 30, 2018 | K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 23, 2018 | K180403 | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 7, 2018 | K180031 | Endopath Electrosurgery Probe Plus II | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| November 20, 2017 | K172580 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 18, 2017 | K163523 | ECHELON CIRCULAR Powered Stapler | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| February 14, 2017 | K163548 | ENSEAL X1 Large Jaw Tissue Sealer | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 5, 2017 | K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 9, 2016 | K160554 | Enseal X1 Large Jaw Tissue Sealer | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 28, 2016 | K160128 | Endopath Electrosurgery Probe Plus II | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 22, 2016 | K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 10, 2015 | K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| July 10, 2015 | K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 18, 2015 | K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| November 24, 2014 | K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| September 15, 2014 | K141122 | HARMONIC SCALLOP BLADE, GENERATOR G11 | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 22, 2014 | K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| December 16, 2013 | K132522 | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| December 3, 2013 | K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 24, 2013 | K132512 | HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 17, 2013 | K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 3, 2013 | K131435 | ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 29, 2013 | K130653 | ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 25, 2013 | K122797 | ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW | GEI | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 1, 2012 | K122511 | ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| August 22, 2012 | K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| July 16, 2012 | K121600 | ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| December 10, 2010 | K101520 | ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH | GEI | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| April 7, 2010 | K100597 | HARMONIC FOCUS SHEARS | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| September 15, 2009 | K092577 | ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| June 1, 2009 | K091322 | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| June 26, 2008 | K081146 | ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 21, 2008 | K080839 | ECHELON GRAY CARTRIDGE, MODEL ERC45M | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| June 13, 2007 | K070198 | ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| May 25, 2007 | K070887 | ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| January 30, 2007 | K063192 | HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP | LFL | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| October 10, 2006 | K062209 | BASX BLADELESS TROCAR | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| April 7, 2006 | K060245 | HARMONIC SCALPEL BLADES AND SHEARS | LFL | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| January 30, 2006 | K053631 | CONTOUR TRANSTAR CURVED CUTTER STAPLER SET | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| October 30, 2003 | K032676 | ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| May 15, 2003 | K030925 | PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| June 5, 2002 | K020779 | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| October 1, 2001 | K012176 | ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 | LFL | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| July 19, 2001 | K011501 | ENDOPOUCH RETRIEVER | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| December 15, 2000 | K002906 | ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 | LFL | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| September 17, 1999 | K990362 | INSTRUMENT, ULTRASONIC, SCALPEL | GEI | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| June 22, 1999 | K984240 | ENDOPATH ENDOSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| February 3, 1999 | K983925 | ENDOPATH ULTRA VERESS NEEDLE | HIF | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| December 18, 1998 | K983536 | PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS | GDW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| October 1, 1997 | K972578 | ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| September 19, 1997 | K972679 | ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| January 8, 1997 | K963760 | NON-SHIELDED SURGICAL TROCAR AND SLEEVE | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| November 4, 1996 | K962584 | ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE | LFL | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| May 27, 1994 | K940967 | MODIFIED ENDOPATH ILS | OCW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| June 22, 1993 | K931111 | ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| April 2, 1992 | K920110 | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | GEA | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 19, 1991 | K910875 | ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE | FDP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 25, 1991 | K904993 | LAPAROSCOPIC ELECTROSURGICAL DEVICE | GEI | Substantially Equivalent | Everest Medical Corp. | accessdata.fda.gov |
| November 5, 1986 | K864102 | LIGACLIP 20/20* MULTIPLE CLIP APPLIER | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 8, 1983 | K830503 | LIGACLIP TITANIUM LIGATING CLIP | FZP | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| May 28, 1982 | K820837 | DISPOSABLE MULTIPLE LIGATING CLIP | GDO | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 7, 2025 | 96461 | Class II | Ongoing | PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP | Identified curing issues with the silicone during the needles manufacturing process. | accessdata.fda.gov |
Compare with other makers
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- All makers of Endoscopic Tissue Approximation Device
- All makers of Applier, Surgical, Clip
- All makers of Electrocautery, Gynecologic (And Accessories)
- All makers of Instrument, Ultrasonic Surgical
Updated May 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.