K950495 is an FDA 510(k) clearance for the SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Surgical Dynamics, Inc. (Concord, US). The FDA issued a Cleared decision on May 9, 1995, 92 days after receiving the submission on February 6, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K950495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1995 |
| Decision Date | May 09, 1995 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |