Key Med Leeds Endoscope Disinfector
by Keymed, Inc.
510(k) K820152
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820152 | Date29 Jan 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FEB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
This device is an accessory for cleaning endoscopes, as defined by its classification name 'Accessories, Cleaning, For Endoscope'. It is intended for use in health care facilities to clean endoscopes following procedures.
The Key Med Leeds Endoscope Disinfector is a reusable device supplied non-sterile. It received FDA 510(k) clearance K820152 on January 29, 1982, and is classified as a Class II medical device under regulation 876.1500 with product code FEB. It is used in gastroenterology and urology settings.
Other devices from Keymed, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Key Med Leeds Endoscope Disinfector used for?
It is an accessory for cleaning endoscopes, intended for use in health care facilities to clean endoscopes following procedures in gastroenterology and urology settings.
Is the Key Med Leeds Endoscope Disinfector sterile or non-sterile when supplied?
The device is supplied non-sterile, as stated in the device data, and is designed for reuse after appropriate cleaning and disinfection by the user.
What regulatory pathway was used for the Key Med Leeds Endoscope Disinfector?
It received FDA 510(k) clearance under number K820152 on January 29, 1982, and is classified as a Class II medical device under regulation 876.1500 with product code FEB.