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FDA 510(k)

Actreen Mini Intermittent Urinary Catheters

K-Number: K151772 · 2016-02-09

ApplicantB.Braun Medical, Inc.
Decision Date2016-02-09
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Actreen Mini Intermittent Urinary Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151772. 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 Actreen Mini Intermittent Urinary Catheters?

Actreen Mini Intermittent Urinary Catheters is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K151772.

When did Actreen Mini Intermittent Urinary Catheters receive FDA 510(k) clearance?

Actreen Mini Intermittent Urinary Catheters received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151772.

Who is the listed applicant for Actreen Mini Intermittent Urinary Catheters?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Actreen Mini Intermittent Urinary Catheters?

The FDA product code for Actreen Mini Intermittent Urinary Catheters is GBM.

Related Clinical Trials

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NCT05232253Cystoealstometer (Bladder Monitor Device)-Home UseACTIVE_NOT_RECRUITINGNCT06985888New Coating for Urinary Intermittent CathetersCOMPLETED

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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 LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

Official Source

View on FDA Database →

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

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