Endoscopic Storage Cover
The Endoscopic Storage Cover (product code OCU) is a gastroenterology and urology accessory designed to protect delicate endoscope components during transport and storage, and may also be used to provide protection during sterilization processes. Proper storage and protection of endoscopes helps extend instrument life and maintain sterility. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCU
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202838 | Andorate Universal Endoscope Tip Guard | Mar 05, 2021 | Substantially Equivalent | Ga Health Company Limited |
| K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | Jan 27, 2020 | Substantially Equivalent | STERIS Corporation |
| K191011 | Scope ProTech | May 07, 2019 | Substantially Equivalent | Meditech Endoscopy, Ltd. |
| K030684 | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH | Jun 03, 2003 | Substantially Equivalent | Acmi Corporation |
| K951104 | ENDOBOOT | Apr 06, 1995 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K940780 | SCOPEJOCKEY | May 10, 1994 | Substantially Equivalent | Fibertech Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.