K961971 is an FDA 510(k) clearance for the Q-5000. This device is classified as a Light, Surgical, Floor Standing (Class II - Special Controls, product code FSS).
Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on June 28, 1996, 39 days after receiving the submission on May 20, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K961971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1996 |
| Decision Date | June 28, 1996 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSS — Light, Surgical, Floor Standing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |