Touriquet Kit with Snare
by Dlp, Inc. 510(k)
Active Open recall
510(k) K855144
Regulatory status
Recall ongoing. 1 ongoing FDA recall names this device. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855144 | Date5 Feb 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Ongoing Z-2423-2024
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Specification
- 510(k) Number
- FDA Product Code
- GDJ
- Device Class
- Class I
- Regulation
- 21 CFR Part 878.4800
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent