Peel-Vue Autoclave/Chemicalve Pouch
510(k) K894437
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Overview
A medical device directory featuring the Peel-Vue Autoclave/CheMicalve Pouch, a widely used and reputable device for sterilization. This device is designed to ensure the removal of microorganisms, making it an essential tool in various healthcare settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894437 | Date10 Jan 1990 | 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- Withdrawn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
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent