510(k) K191011
- Device
- Scope ProTech
- Applicant
- Meditech Endoscopy Ltd
- 510(k) number
- K191011
- Product code
- OCU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-07
- Date received
- 2019-04-16
- Regulation
- 876.1500
- Classification name
- Endoscopic Storage Cover
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Peter Ramsey
- Address
- Bowden House, Luckyn Ln. Basildon GB ss14 3ax ss14 3ax
FDA Registration Numbers#
- 1528319
- 3011346938
- 2246552
- 3008058134
- 3014749926
- 1047843
- 3011050570
- 1519132
- 3003790304
Source Documents#
Other 510(k) Records For Product Code OCU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202838 | Andorate Universal Endoscope Tip Guard | Ga Health Company Limited | 2021-03-05 |
| K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | STERIS Corporation | 2020-01-27 |
| K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | Acmi Corporation | 2003-06-03 |
| K951104 | ENDOBOOT | United States Endoscopy Group, Inc. | 1995-04-06 |
| K940780 | SCOPEJOCKEY | Fibertech Instruments, Inc. | 1994-05-10 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases