K954726 is an FDA 510(k) clearance for the STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION). 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 29, 1995, 118 days after receiving the submission on August 3, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K954726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1995 |
| Decision Date | November 29, 1995 |
| Days to Decision | 118 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 |