Data / Medical devices / Snare, Flexible
Snare, Flexible (FDI): 42 FDA-registered makers in 11 countries
42 establishments in 11 countries are registered with the FDA to make Snare, Flexible (product code FDI, Class 2, 21 CFR 876.4300). 28 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 63 510(k) clearances under this code, the latest on February 21, 2026, and lists 7 recall events (0 Class I). 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.
- Product code
- FDI
- Device class
- 2
- Regulation
- 876.4300
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Germany | 8 |
| China | 7 |
| Japan | 3 |
| Thailand | 3 |
| Costa Rica | 2 |
| South Korea | 2 |
| Ireland | 1 |
| Vietnam | 1 |
| Mexico | 1 |
| Czechia | 1 |
Makers of Snare, Flexible
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 9 | October 7, 2021 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 7 | October 8, 2020 | 0 | 3 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 7 | October 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 7 | October 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 6 | October 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Horizons Intl. Corp. | Heredia, Costa Rica | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | December 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 2 | December 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer, Repackager or relabeler | 2 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 2 | February 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 2 | February 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 2 | December 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Olympus Vietnam Co. Ltd. | Dong Nai City, Vietnam | Manufacturer | 2 | December 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 2 | July 18, 2019 | 0 | 1 | 0 | api.fda.gov |
| Ags Medtech (thailand) Co., Ltd. | Pluak Daeng District Rayong, Thailand | Manufacturer, Repackager or relabeler | 1 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 1 | October 13, 1992 | 0 | 0 | 0 | api.fda.gov |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Manufacturer | 1 | June 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | July 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | June 7, 1993 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | June 7, 1993 | 0 | 0 | 0 | api.fda.gov |
| Finemedix | Daegu Gwangyeogsi, South Korea | Manufacturer | 1 | March 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Incore Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | November 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, China | Manufacturer | 1 | September 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medi-Globe GMBH | Achenmuhle, Germany Bavaria, Germany | Manufacturer | 1 | May 26, 1995 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech Medical Technology (Thailand) Co., Ltd. | Bang Lamung District Chon Buri, Thailand | Manufacturer | 1 | July 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ovesco Endoscopy AG | Tuebingen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 1 | November 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| TeleMed Systems | Northborough, MA, United States | Specification developer | 1 | June 18, 1990 | 0 | 0 | 0 | api.fda.gov |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 1 | June 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 1 | March 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asahi Intecc (thailand) Co., Ltd. | Amphur Muang Pathumthani Pathum Thani, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | S Plainfield, NJ, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi-Globe Sro | HRANICE Olomouc, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 21, 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.