K910377 is an FDA 510(k) clearance for the COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by CooperSurgical, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 19, 1991, 80 days after receiving the submission on January 29, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K910377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1991 |
| Decision Date | April 19, 1991 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |