K900370 is an FDA 510(k) clearance for the ONE/CIRC (CIRCUMCISION CLAMP). This device is classified as a Clamp, Circumcision (Class II - Special Controls, product code HFX).
Submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on April 16, 1990, 81 days after receiving the submission on January 25, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K900370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1990 |
| Decision Date | April 16, 1990 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFX — Clamp, Circumcision |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |