FDA Product Code
FDA Product Code OCU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202838 | Andorate Universal Endoscope Tip Guard | Ga Health Company Limited | 2021-03-05 | Traditional | PDF ↗ |
| K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | STERIS Corporation | 2020-01-27 | Traditional | PDF ↗ |
| K191011 | Scope ProTech | Meditech Endoscopy, Ltd. | 2019-05-07 | Traditional | PDF ↗ |
| K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | Acmi Corporation | 2003-06-03 | Traditional | PDF ↗ |
| K951104 | ENDOBOOT | United States Endoscopy Group, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K940780 | SCOPEJOCKEY | Fibertech Instruments, Inc. | 1994-05-10 | Traditional | PDF ↗ |
Product code OCU · Class II · Gastroenterology, Urology. Data: openFDA.