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510(k) K182511

SimplCath by F&S Medical Solutions, LLC — Product Code GBM

K182511 is an FDA 510(k) premarket notification submitted by F&S Medical Solutions, LLC for the device "SimplCath". The FDA issued a decision of Substantially Equivalent on March 20, 2019. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2019
Date Received
September 12, 2018
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

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  • K200820 — SpeediCath Compact Set (November 13, 2020)
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  • K200142 — SpeediCath Soft (July 30, 2020)
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  • 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)

FDA data resources