Home / 510(k) Clearances / K101900

510(k) K101900

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH by Hakki Medical Technologies, Inc. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2011
Date Received
July 7, 2010
Clearance Type
Traditional
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 Hakki Medical Technologies, Inc.

  • K191512 — LotusCatheter (Lotus No Balloon Catheter) (May 21, 2020)

Other clearances for product code GBM

  • K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic In (March 5, 2025)
  • K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (June 22, 2022)
  • 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)