Data / Medical devices / Gastroscope And Accessories, Flexible/Rigid / United States
FDA-registered makers of Gastroscope And Accessories, Flexible/Rigid in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Gastroscope And Accessories, Flexible/Rigid (product code FDS). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Gastroscope And Accessories, Flexible/Rigid
- Product code
- FDS
- Country
- United States
Makers of Gastroscope And Accessories, Flexible/Rigid in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Evoendo, Inc. | Grayslake, IL, United States | Specification developer | 2 | October 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Actuated Medical, Inc. | Bellefonte, PA, United States | Manufacturer | 1 | October 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 1 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Neptune Medical, Inc | Burlingame, CA, United States | Complaint file establishment, Manufacturer | 1 | May 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Visura Technologies, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | June 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cordica Medical, Inc. | Sunrise, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.