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510(k) K183253

ValPro 2 Plus, VaPro 2 Plus Pocket by Hollister Incorporated — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2018
Date Received
November 21, 2018
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

  • K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (n (October 3, 2025)
  • K233524 — Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (N (May 3, 2024)
  • K220667 — Sleeved IC (December 8, 2022)
  • K213575 — Female IC (Not Finalized) (September 13, 2022)
  • K211436 — Intermittent Catheter (Not Finalized) (January 27, 2022)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)
  • K191633 — Infyna Chic (July 19, 2019)
  • K180824 — VaPro 2 Intermittent Catheter (June 22, 2018)
  • 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)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)