Data / Medical devices / Image, Illumination, Fiberoptic, For Endoscope
Image, Illumination, Fiberoptic, For Endoscope (FFS): 16 FDA-registered makers in 3 countries
16 establishments in 3 countries are registered with the FDA to make Image, Illumination, Fiberoptic, For Endoscope (product code FFS, Class 2, 21 CFR 876.1500). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on November 20, 2007, and lists 2 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
- FFS
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| Germany | 1 |
| Nicaragua | 1 |
Makers of Image, Illumination, Fiberoptic, For Endoscope
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 |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 2 | September 4, 1996 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | November 20, 2007 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | November 20, 2007 | 0 | 0 | 0 | api.fda.gov |
| Microvision, Inc. | Seabrook, NH, United States | Manufacturer | 1 | September 14, 1998 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | January 20, 2000 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 1 | January 20, 2000 | 0 | 0 | 0 | api.fda.gov |
| Cogentix Medical, Inc. | Orangeburg, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogentix Medical, Inc. | Westborough, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Nicaragua SA | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulf Fiberoptics, Inc. | Oldsmar, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | 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 | |
| Katalyst Surgical, LLC | Chesterfield, MO, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 20, 2007. 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.