510(k) K014002
K014002 is an FDA 510(k) premarket notification submitted by Fortune Medical Instrument Corp. for the device "ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890". The FDA issued a decision of Substantially Equivalent on March 4, 2002. The device falls under product code KOB (Catheter, Suprapubic (And Accessories)), a Class II device regulated under 21 CFR 876.5090. Fortune Medical Instrument Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2002
- Date Received
- December 4, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Suprapubic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5090
- Review Panel
- GU
- Submission Type