Data / Medical devices / Endoscopic Storage Cover
Endoscopic Storage Cover (OCU): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Endoscopic Storage Cover (product code OCU, Class 2, 21 CFR 876.1500). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 5, 2021, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OCU
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Hong Kong | 1 |
| United Kingdom | 1 |
| China | 1 |
Makers of Endoscopic Storage Cover
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 | Manufacturer | 2 | January 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ga Health Company Limited | Hong Kong, Hong Kong | Complaint file establishment, Exporter to the US, Specification developer | 1 | March 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | June 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Meditech Endoscopy Ltd | Basildon Essex, United Kingdom | Manufacturer | 1 | May 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nissha Medical Technologies (Ohio), Inc. | Norwalk, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartdata Suzhou Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 5, 2021. 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.