510(k) K152268

VAPRO PLUS POCKET Intermittent Catheter by Hollister Incorporated — Product Code GBM

K152268 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "VAPRO PLUS POCKET Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on September 9, 2015. 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
September 9, 2015
Date Received
August 11, 2015
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