Data / Medical devices / Sigmoidoscope And Accessories, Flexible/Rigid
Sigmoidoscope And Accessories, Flexible/Rigid (FAM): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Sigmoidoscope And Accessories, Flexible/Rigid (product code FAM, Class 2, 21 CFR 876.1500). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on June 27, 1997, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FAM
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Germany | 5 |
| Japan | 4 |
| United States | 2 |
| Malaysia | 1 |
| Denmark | 1 |
| Ireland | 1 |
| Estonia | 1 |
Makers of Sigmoidoscope And Accessories, Flexible/Rigid
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 |
|---|---|---|---|---|---|---|---|---|
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer, Specification developer | 2 | April 23, 1979 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 1 | March 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 1 | March 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| Ambu SDN.BHD. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ambu A/S | Ballerup Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HONER Medizin-Technik GmbH & Co. KG | SPAICHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inmo-Tech Ltd. | Sligo, Ireland | 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 | |
| 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 | |
| Karl Storz Video Endoscopy Estonia Oue | Laagri Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 27, 1997. 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.