K961122 is an FDA 510(k) clearance for the STRYKER KNIFELIGHT. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 22, 1996, 154 days after receiving the submission on March 21, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K961122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1996 |
| Decision Date | August 22, 1996 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTD — Lamp, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |