K100884 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 Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on June 25, 2010, 87 days after receiving the submission on March 30, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K100884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2010 |
| Decision Date | June 25, 2010 |
| Days to Decision | 87 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 |