510(k) K110862
K110862 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "VAPRO PLUS INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on April 26, 2011. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hollister Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2011
- Date Received
- March 29, 2011
- Clearance Type
- Special
- 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