K961904 is an FDA 510(k) clearance for the AQ HYDROPHILIC DILATORS. This device is classified as a Dilator, Urethral (Class II - Special Controls, product code KOE).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 18, 1996, 155 days after receiving the submission on May 16, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K961904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1996 |
| Decision Date | October 18, 1996 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOE — Dilator, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5520 |