510(k) K140953
K140953 is an FDA 510(k) premarket notification submitted by Convatec, Ltd. for the device "GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER". The FDA issued a decision of Substantially Equivalent on August 1, 2014. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Convatec, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2014
- Date Received
- April 14, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type