OCU
6 FDA 510(k) clearances · Product code
90 daysmedian time to decision
215 days90th percentile
6clearances measured
FDA profile
- Official device name
- Endoscopic Storage Cover
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Andorate Universal Endoscope Tip Guard (K202838) | Ga Health Company Limited | 2021-03-05 | + Add |
| Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile (K191715) | STERIS Corporation | 2020-01-27 | + Add |
| Scope ProTech (K191011) | Meditech Endoscopy, Ltd. | 2019-05-07 | + Add |
| SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH (K030684) | Acmi Corporation | 2003-06-03 | + Add |
| ENDOBOOT (K951104) | United States Endoscopy Group, Inc. | 1995-04-06 | + Add |
| SCOPEJOCKEY (K940780) | Fibertech Instruments, Inc. | 1994-05-10 | + Add |
Track OCU automatically
Every clearance here is in the API, with alerts when new ones post.