510(k) K160795
K160795 is an FDA 510(k) premarket notification submitted by Robling Medical for the device "United Urologics Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on Jun 16, 2016. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Robling Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2016
- Date Received
- Mar 23, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type