K014002 is an FDA 510(k) clearance for the ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890, a Catheter, Suprapubic (and Accessories) (Class II — Special Controls, product code KOB), submitted by Fortune Medical Instrument Corp. (Taipei Hsien, TW). The FDA issued a Cleared decision on March 4, 2002, 90 days after receiving the submission on December 4, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K014002 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 04, 2001 |
| Decision Date | March 04, 2002 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOB — Catheter, Suprapubic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5090 |