K960426 is an FDA 510(k) clearance for the MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER. This device is classified as a Catheter, Peritoneal (Class I - General Controls, product code GBW).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on March 21, 1996, 52 days after receiving the submission on January 29, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K960426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1996 |
| Decision Date | March 21, 1996 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBW — Catheter, Peritoneal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |