510(k) K232665
K232665 is an FDA 510(k) premarket notification submitted by Convatec for the device "GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)". The FDA issued a decision of Substantially Equivalent on January 25, 2024. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Convatec has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2024
- Date Received
- August 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type