K935697 is an FDA 510(k) clearance for the CIRCUMCISION TRAY. This device is classified as a Clamp, Circumcision (Class II - Special Controls, product code HFX).
Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on May 2, 1994, 153 days after receiving the submission on November 30, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K935697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | November 30, 1993 |
| Decision Date | May 02, 1994 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFX — Clamp, Circumcision |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |