510(k) K160877
K160877 is an FDA 510(k) premarket notification submitted by Robling Medical, Inc. for the device "United Urologics Closed System Catheter". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Robling Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2016
- Date Received
- Mar 30, 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