Scope ProTech
510(k) K191011
Scope ProTech is a Class II device made by Meditech Endoscopy, Ltd., cleared under FDA 510(k) K191011 on 7 May 2019, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191011 | Date7 May 2019 | StatusActive |
Official records
- FDA 510(k) database K191011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OCU
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191011
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Protech L INOV8-028L | INOV8-028L | 05060602250314 | — | On the market |
| Protech S INOV8-028S | INOV8-028S | 05060602250321 | — | On the market |
| Protech XL INOV8-044 | INOV8-044 | 05060602250567 | — | On the market |
Similar devices
Other devices filed under FDA product code OCU (Endoscopic Storage Cover).
- Endo-Boot 00711621 by US Endoscopy
- ProArmor 00711624 by US Endoscopy
- Andorate Universal Endoscope Tip Guard by GA HEALTH COMPANY LIMITED
- SCOPEJOCKEY by Fibertech Instruments, Inc.
- Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile by STERIS CORPORATION
- ENDOBOOT by United States Endoscopy Group, Inc.
- SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH by Acmi Corporation