K102141 is an FDA 510(k) clearance for the COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED). This device is classified as a Instrument, Manual, Specialized Obstetric-gynecologic (Class II - Special Controls, product code KNA).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on May 6, 2011, 281 days after receiving the submission on July 29, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K102141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2010 |
| Decision Date | May 06, 2011 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |