OCU — Endoscopic Storage Cover Class II
Classification Details
- Product Code
- OCU
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202838 | ga health company limited | Andorate Universal Endoscope Tip Guard | March 5, 2021 |
| K191715 | steris corporation | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | January 27, 2020 |
| K191011 | meditech endoscopy | Scope ProTech | May 7, 2019 |
| K030684 | acmi corporation | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | June 3, 2003 |
| K951104 | united states endoscopy group | ENDOBOOT | April 6, 1995 |
| K940780 | fibertech instruments | SCOPEJOCKEY | May 10, 1994 |