K943950 is an FDA 510(k) clearance for the ETHICON NONABSORBABLE SUTURE ANCHOR. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 30, 1995, 288 days after receiving the submission on August 15, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K943950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 15, 1994 |
| Decision Date | May 30, 1995 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |