K023382 is an FDA 510(k) clearance for the COOPERSURGICAL MALLEABLE SYTLET, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Cooper Surgical (Huntington, US). The FDA issued a Cleared decision on December 20, 2002, 73 days after receiving the submission on October 8, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K023382 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 08, 2002 |
| Decision Date | December 20, 2002 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF — Catheter, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6110 |