K991167 is an FDA 510(k) clearance for the STERIS SMOKE EVACUATION SYSTEM. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).
Submitted by STERIS Corporation (Montgomery, US). The FDA issued a Cleared decision on June 3, 1999, 57 days after receiving the submission on April 7, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K991167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1999 |
| Decision Date | June 03, 1999 |
| Days to Decision | 57 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYD — Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |