FDA 510(k)

SimplCath

K-Number: K182511 · 2019-03-20

Decision Date2019-03-20

Product CodeGBM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SimplCath is the device name listed in this FDA 510(k) record. The listed applicant is F&S Medical Solutions, LLC. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K182511. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimplCath?

SimplCath is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is F&S Medical Solutions, LLC. The 510(k) number is K182511.

When did SimplCath receive FDA 510(k) clearance?

SimplCath received FDA 510(k) clearance on 2019-03-20, under 510(k) number K182511.

Who is the listed applicant for SimplCath?

The FDA 510(k) record lists F&S Medical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimplCath?

The FDA product code for SimplCath is GBM.

Related Devices (Code: GBM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.