510(k) K160858
K160858 is an FDA 510(k) premarket notification submitted by Compactcath, Inc. for the device "CompactCath Intermittent Urinary Catheter". The FDA issued a decision of Substantially Equivalent on Apr 26, 2016. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Compactcath, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 26, 2016
- Date Received
- Mar 29, 2016
- Clearance Type
- Special
- 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
- 510(k)