Data / Medical devices / Endoscopic Contamination Prevention Sheath
Endoscopic Contamination Prevention Sheath (ODB): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Endoscopic Contamination Prevention Sheath (product code ODB, Class 2, 21 CFR 876.1500). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on October 8, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ODB
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| United States | 3 |
Makers of Endoscopic Contamination Prevention Sheath
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 |
|---|---|---|---|---|---|---|---|---|
| Insightra Medical, Inc. | Clarksville, TN, United States | Complaint file establishment, Specification developer | 1 | June 10, 2008 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 1 | September 14, 1994 | 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 | |
| Sheathing Technologies, Inc. | Morgan Hill, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Usgi Medical | San Clemente, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 8, 2019. 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.