Data / Medical devices / Japan / AOMORI OLYMPUS CO., LTD. Kuroishi Site
AOMORI OLYMPUS CO., LTD. Kuroishi Site: FDA-registered device maker in KUROISHI-SHI Aomori, Japan, 82 510(k) clearances
AOMORI OLYMPUS CO., LTD. Kuroishi Site is registered with the FDA (registration 9614641) in KUROISHI-SHI Aomori, Japan. It lists 35 device types. The FDA files 82 510(k) clearances under its listings, the newest dated August 27, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9614641
- FEI number
- 3003995201
- Address
- 2-248-1 Okkonoki, KUROISHI-SHI Aomori, Japan, 036-0357
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 20, 2002
- Registered through
- 2027
- Brand names listed
- B-V233P-A, B-V233P-B, B-V243Q-A, B-V243Q-B, B-V433P-A, B-V433P-B, B-V443Q-A, B-V443Q-B 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 |
|---|---|---|---|---|---|---|
| August 27, 2026 | K260856 | Disposable Distal Attachment D-201-13404 | FDS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 1, 2026 | K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | GEI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| May 21, 2026 | K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | PKL | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 6, 2026 | K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | KGE | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 18, 2025 | K250993 | Single Use Cytology Brush V (BC-V600P-3010) | FDX | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| November 25, 2025 | K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | KNS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 24, 2025 | K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | FCG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 21, 2025 | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | FGE | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 17, 2025 | K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 10, 2025 | K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | KNS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 7, 2025 | K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | GEI | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 12, 2025 | K251279 | Disposable Cytology Brush BC-202D/203D Series | BTG | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 4, 2025 | K250118 | Disposable Balloon Catheter B5-2C | EOQ | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 27, 2025 | K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | ODD | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| May 1, 2025 | K250296 | Disposable Distal Attachment D-201 Series | FDS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 31, 2025 | K250263 | Disposable Grasping Forceps FG-52D/FG-54D | KTI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 18, 2025 | K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | LQR | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 3, 2024 | K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | PKL | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 22, 2021 | K212667 | Single Use Guide Sheath Kit-401, K-402 | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 4, 2021 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | LFL | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| December 17, 2020 | K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 28, 2020 | K192498 | Single Use Injector | FBK | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 24, 2020 | K200397 | Single Use Biopsy Forceps FB-456D | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 6, 2020 | K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 17, 2019 | K193039 | Single Use Balloon Dilator V (with knife) | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 10, 2019 | K190239 | Single Use Aspiration Needle | KTI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| August 2, 2019 | K190293 | Single Use Cytology Brush BC-205D | BTG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| May 15, 2019 | K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| November 30, 2018 | K173495 | Single Use Hot Biopsy Forceps FD-231 | QEC | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| November 15, 2018 | K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | FCG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 31, 2018 | K181994 | Single Use Aspiration Needle NA-U201H | FCG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 8, 2018 | K180449 | Single Use Aspiration Needle NA-U200H | FCG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 30, 2018 | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 7, 2017 | K172734 | Single Use Electrosurgical Snare SD-400 | FDI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| November 27, 2017 | K170811 | Single Use Retrieval Nitinol Basket V | LQR | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| November 17, 2017 | K171158 | Single Use Electrosurgical knife | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 13, 2017 | K171916 | Single Use Hot Biopsy Forceps FD-231 | KGE | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 4, 2017 | K172691 | Ultrasonic Generator | LFL | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 22, 2016 | K160098 | Single Use Aspiration Needle NA-U401SX | FCG | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 2, 2016 | K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 12, 2016 | K153625 | Single Use Injector NM600/610 | FBK | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 8, 2015 | K150142 | Single Use Balloon Dilator V (with Knife) | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| March 31, 2015 | K141991 | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP | KNS | Substantially Equivalent | Olympus Medical Systems Copr. | accessdata.fda.gov |
| February 27, 2015 | K143303 | Single Use Biliary Balloon Dilator | FGE | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 29, 2013 | K123601 | SINGLE USE REPOSITIONABLE CLIP | PKL | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 11, 2013 | K122505 | SINGLE USE PRELOADED SPHINCTEROTOME V | KNS | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 20, 2012 | K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM | GEI | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| February 24, 2011 | K103478 | SINGLE USE BILIARY DRAINAGE STENT V | FGE | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| October 30, 2009 | K092309 | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L | KNS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| September 3, 2009 | K091495 | SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A | LQR | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| December 22, 2006 | K062517 | ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES | KGE | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 1, 2005 | K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | FDF | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| June 3, 2005 | K050885 | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG | LFL | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| May 12, 2005 | K050503 | SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 | FCG | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| January 25, 2005 | K042160 | SONOSURG TROCAR | LFL | Substantially Equivalent | Aomori Olympus Co., Ltd. | accessdata.fda.gov |
| September 8, 2004 | K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | LFL | Substantially Equivalent | Aomori Olympus Co., Ltd. | accessdata.fda.gov |
| August 18, 2004 | K042140 | OLYMPUS BF TYPE UC160-OL8 | ODG | Substantially Equivalent | Olympus Corporation | accessdata.fda.gov |
| October 3, 2003 | K032066 | SONOSURG SYSTEM | LFL | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| April 16, 2003 | K021672 | PANCREATIC DRAINAGE TUBE | FGE | Substantially Equivalent | Aomori Olympus Co., Ltd. | accessdata.fda.gov |
| December 19, 2002 | K023280 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | GEI | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| January 30, 2002 | K013617 | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS | GCJ | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| December 26, 2001 | K013591 | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT | EOB | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| December 11, 2001 | K013066 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE | MND | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| May 15, 2001 | K011149 | DISPOSABLE BENDING CANNULA PR-233Q | ODD | Substantially Equivalent | The Olympus Optical Co. | accessdata.fda.gov |
| March 15, 2001 | K010591 | OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER | ODG | Substantially Equivalent | Olympus Optical Co., Ltd. | accessdata.fda.gov |
| September 17, 1999 | K984358 | OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 | FDS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| October 25, 1996 | K962925 | OLYMPUS B-5/B-7 SERIESBALLOON CATHETER | FGE | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| September 16, 1996 | K961048 | OLYMPUS MH-246R BALLOON SHEATH | ODG | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 20, 1996 | K962901 | OLYMPUS B5-2C/B7-2C BALLOON CATHETER | EOQ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| August 2, 1996 | K962378 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | EOQ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| April 30, 1996 | K955247 | OLYMPUS KD SERIES SPHINCTEROTOME | KNS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| March 29, 1996 | K955650 | OLYMPUS SD SERIES SNARES | FDI | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| January 22, 1996 | K955063 | OLYMPUS BASKET GRASPERS | OCZ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| April 5, 1995 | K933200 | OLYMPUS PBD STENTS | FGE | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| March 17, 1995 | K950729 | OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) | ODD | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 27, 1995 | K950636 | OLYMPUS DISPOSABLE BIOPSY FORCEPS | EOQ | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| February 22, 1995 | K950166 | OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE | KNS | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| October 7, 1993 | K931154 | EVIS 200 SYSTEM | EOQ | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 7, 1991 | K912120 | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE | FBN | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 24, 1990 | K902737 | BC BRUSHES | FDX | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 24, 1990 | K902736 | NM INJECTION NEEDLES | FBK | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
| August 2, 1990 | K902735 | SD SNARES | GEI | Substantially Equivalent | Olympus Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 27, 2023 | 92784 | Class II | Ongoing | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012 | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 | accessdata.fda.gov |
| January 4, 2021 | 87074 | Class II | Terminated | B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope Accessory
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- All makers of Snare, Flexible
Updated August 27, 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.