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510(k) K193148

VaPro Plus Pocket, VaPro Plus by Hollister Incorporated — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2019
Date Received
November 13, 2019
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

Other clearances by Hollister Incorporated

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  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
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  • K163179 — Onli Intermittent Catheter (January 26, 2017)
  • K152268 — VAPRO PLUS POCKET Intermittent Catheter (September 9, 2015)

Other clearances for product code GBM

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  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
  • K200820 — SpeediCath Compact Set (November 13, 2020)
  • K192904 — SpeediCath Compact Set (November 2, 2020)
  • K200142 — SpeediCath Soft (July 30, 2020)
  • K200134 — Jimushi Sterile Urethral Catheter for single use (June 1, 2020)
  • K191512 — LotusCatheter (Lotus No Balloon Catheter) (May 21, 2020)
  • K192577 — Actreen Hi-Lite Intermittent Urinary Catheters (May 7, 2020)
  • K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to (November 27, 2019)