K843942 is an FDA 510(k) clearance for the HENNING MENISCAL SUTURE KIT. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on April 15, 1985, 188 days after receiving the submission on October 9, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K843942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1984 |
| Decision Date | April 15, 1985 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |