Resubmitted Juniper T.M. Joint Distraction Forceps
by Downs Surgical, Ltd. 510(k)
Active
510(k) K881757
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881757 | Date15 Jul 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ETN
- FDA applicant
- Downs Surgical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.1820
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent