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510(k) K191512

LotusCatheter (Lotus No Balloon Catheter) by Hakki Medical Technologies, Inc. — Product Code GBM

K191512 is an FDA 510(k) premarket notification submitted by Hakki Medical Technologies, Inc. for the device "LotusCatheter (Lotus No Balloon Catheter)". The FDA issued a decision of Substantially Equivalent (kit) on May 21, 2020. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hakki Medical Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 21, 2020
Date Received
June 7, 2019
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.

  • K101900 — HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH (February 7, 2011)

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)
  • K192577 — Actreen Hi-Lite Intermittent Urinary Catheters (May 7, 2020)
  • K193148 — VaPro Plus Pocket, VaPro Plus (December 13, 2019)
  • K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to (November 27, 2019)

FDA data resources