K970186 is an FDA 510(k) clearance for the GI SUPPLY PARACENTESIS PUMP. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Gi Supply (Willington, US). The FDA issued a Cleared decision on February 14, 1997, 28 days after receiving the submission on January 17, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K970186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1997 |
| Decision Date | February 14, 1997 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | BTA - Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |