K052365 is an FDA 510(k) clearance for the CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE. This device is classified as a Set, Anesthesia, Paracervical (Class II - Special Controls, product code HEE).
Submitted by Rocket Medical Plc (Tyne & Wear, GB). The FDA issued a Cleared decision on October 17, 2005, 49 days after receiving the submission on August 29, 2005.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5100.
| 510(k) Number | K052365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2005 |
| Decision Date | October 17, 2005 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEE - Set, Anesthesia, Paracervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5100 |