510(k) K161344
K161344 is an FDA 510(k) premarket notification submitted by Convatec Limited for the device "GentleCath Glide Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on September 20, 2016. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Convatec Limited has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2016
- Date Received
- May 13, 2016
- 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