K932205 is an FDA 510(k) clearance for the ERCP CATHETER, HYDROPHILIC COATED. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 3, 1994, 242 days after receiving the submission on May 6, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K932205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1993 |
| Decision Date | January 03, 1994 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |