Mic Peg Tube
510(k) K924065
Active
510(k)
Valid until
No expiry
FDA recalls
12 ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SEKD | NumberK924065 | Date17 Feb 1994 | StatusActive |
Recalls
-
- Ongoing Z-2343-2026
- Ongoing Z-2348-2026
- Ongoing Z-2346-2026
- Ongoing Z-2344-2026
- Ongoing Z-2352-2026
- Ongoing Z-2347-2026
- Ongoing Z-2349-2026
- Ongoing Z-2342-2026
- Ongoing Z-2350-2026
- Ongoing Z-2345-2026
- Ongoing Z-2351-2026
- Ongoing Z-2341-2026
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
-
- Terminated Z-0566-2022
- Terminated Z-0565-2022
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SEKD