K964219 is an FDA 510(k) clearance for the ZIP CONDOM CATHETER. This device is classified as a System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (Class I - General Controls, product code EYZ).
Submitted by Goulter Medical, Inc. (Concord, US). The FDA issued a Cleared decision on August 11, 1997, 293 days after receiving the submission on October 22, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K964219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1996 |
| Decision Date | August 11, 1997 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYZ — System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |