Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
510(k) K152081
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152081 | Date26 Aug 2015 | StatusActive |
Recalls
-
- Terminated Z-0083-2018
The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FZP
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent