K963648 is an FDA 510(k) clearance for the STRYKER SUCTION REGULATOR. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on November 26, 1996, 75 days after receiving the submission on September 12, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K963648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1996 |
| Decision Date | November 26, 1996 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |