K130087 is an FDA 510(k) clearance for the PANPAC WORD/BARTHOLIN CATHETER, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW). The FDA issued a Cleared decision on January 10, 2014, 361 days after receiving the submission on January 14, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K130087 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 2013 |
| Decision Date | January 10, 2014 |
| Days to Decision | 361 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |