K990349 is an FDA 510(k) clearance for the WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST. This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on July 26, 1999, 171 days after receiving the submission on February 5, 1999.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K990349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1999 |
| Decision Date | July 26, 1999 |
| Days to Decision | 171 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 |