Data / Medical devices / United States / Stryker Sustainability Solutions Lakeland
Stryker Sustainability Solutions Lakeland: FDA-registered device maker in Lakeland, FL, United States, 45 510(k) clearances
Stryker Sustainability Solutions Lakeland is registered with the FDA (registration 1056128) in Lakeland, FL, United States. It lists 9 device types. The FDA files 45 510(k) clearances under its listings, the newest dated August 14, 2025. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1056128
- FEI number
- 1000132435
- Address
- 5307 Great Oak Drive, Lakeland, FL, United States, 33815
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Remanufacturer, Reprocessor
- First device listed
- February 5, 2010
- Registered through
- 2027
- Brand names listed
- Remanufactured LigaSure Exact Dissector Without Nano-coating, Remanufactured LigaSure Exact Dissector, Without Nano-coating, Reprocessed Arthroscopic Cutters, Reprocessed Arthroscopic Wand, Reprocessed Arthroscopic Wands, Reprocessed Blunt Tip Laparoscopic Sealer/Divider, Reprocessed Electrosurgical Laparoscopic Endoscoipic Instruments, Reprocessed Endoscopic Instruments and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Reprocessor | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Remanufacturer, Reprocessor | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | 2 | Reprocessor | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Reprocessor | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Reprocessor | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Reprocessor | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery, Reprocessed | NLM | 2 | Reprocessor | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Reprocessor | accessdata.fda.gov |
| Single-Use Reprocessed Ultrasonic Surgical Instruments | NLQ | U | Reprocessor | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 14, 2025 | K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 3, 2024 | K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| February 20, 2024 | K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 28, 2023 | K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 28, 2023 | K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 25, 2022 | K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 13, 2022 | K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| March 16, 2021 | K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| September 25, 2020 | K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent | HIH | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 31, 2020 | K201511 | Reprocessed Endoscopic Trocars and Sleeves | NLM | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 20, 2018 | K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| November 16, 2017 | K172856 | Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider | GEI | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 5, 2017 | K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| February 23, 2017 | K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| May 1, 2014 | K133672 | REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY | NLQ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| April 10, 2014 | K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| December 31, 2013 | K132629 | REPROCESSED DILATING TIP TROCARS | NLM | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| August 16, 2012 | K121855 | RESPROCESSED SERFAS ENERGY PROBE | NUJ | Substantially Equivalent | Stryker Sustainability Solutions | accessdata.fda.gov |
| July 18, 2011 | K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT | NUJ | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| May 12, 2010 | K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE | NLQ | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| March 19, 2010 | K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | NLM | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| March 4, 2010 | K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | NLQ | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| October 15, 2007 | K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | NLM | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| October 2, 2007 | K070059 | REPROCESSED TROCARS | NLM | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| January 31, 2007 | K062497 | REPROCESSED TROCARS | NLM | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| October 11, 2006 | K053585 | VANGUARD REPROCESSED SUTURE PASSER | NLM | Substantially Equivalent | Ascent Healthcare Solutions | accessdata.fda.gov |
| June 6, 2005 | K043358 | REPROCESSED ULTRASONIC SCALPELS | NLQ | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| May 27, 2005 | K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | NUJ | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| April 8, 2005 | K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | NLM | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| March 31, 2005 | K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES | NLM | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| March 22, 2005 | K043315 | VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL | NLQ | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| March 22, 2005 | K043225 | VANGUARD REPROCESSED ULTRASONIC SCALPEL | NLQ | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| March 4, 2003 | K024015 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | NLM | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| December 6, 2001 | K012631 | REPROCESSED SOFT TISSUE ABLATORS | GEI | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 9, 2001 | K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | HRX | Substantially Equivalent | Alliance Medical, Inc. | accessdata.fda.gov |
| November 8, 2001 | K012652 | REPROCESSED DYONICS ARTHROSCOPIC BURS | HRX | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 7, 2001 | K012700 | VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| November 7, 2001 | K012635 | REPROCESSED STRYKER ARTHROSCOPIC SHAVERS | HRX | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 7, 2001 | K012613 | REPROCSSED LINVATEC SHAVERS | HRX | Substantially Equivalent | Alliance Medical, Inc. | accessdata.fda.gov |
| November 7, 2001 | K012605 | REPROCESSED ATHROSCOPICS BURS | HRX | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| November 7, 2001 | K012603 | REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS | NUJ | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| October 30, 2001 | K012695 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | GEI | Substantially Equivalent | Vanguard Medical Concepts, Inc. | accessdata.fda.gov |
| October 22, 2001 | K012625 | REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Alliance Medical Corp. | accessdata.fda.gov |
| October 16, 2001 | K012346 | VANGUARD REPROCESSED ARTHROSCOPIC BLADES | HRX | Substantially Equivalent | Vanguard Medical Concepts, 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 |
|---|---|---|---|---|---|---|
| June 23, 2010 | 56157 | Not yet classified | Terminated | ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165. | The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated. | accessdata.fda.gov |
| June 1, 2009 | 61296 | Not yet classified | Terminated | The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generat | On 06/09/2009, Stryker Sustain ability Solutions, formerly Ascent Healthcare Solutions, recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09. | accessdata.fda.gov |
| March 11, 2008 | 47343 | Not yet classified | Terminated | Kendall Calf Garment - Reprocessed Sterile device used to cover calf while conducting sterile procedures. | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. | accessdata.fda.gov |
| October 19, 2006 | 37162 | Not yet classified | Terminated | AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length. | The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging. | accessdata.fda.gov |
| March 17, 2006 | 35506 | Not yet classified | Terminated | Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL | Review of complaints and testing show that the distal tip of the trocars may separate while in use. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery, Reprocessed
- All makers of Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- All makers of Single-Use Reprocessed Ultrasonic Surgical Instruments
- All makers of Instrument, Ultrasonic Surgical
- All makers of Arthroscope
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated August 14, 2025. 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.