Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medline Poly-Cath Red Polymer Urethral Catheter

K-Number: K183335 · 2019-06-12

ApplicantMedline Industries, Inc.
Decision Date2019-06-12
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline Poly-Cath Red Polymer Urethral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K183335. 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 Medline Poly-Cath Red Polymer Urethral Catheter?

Medline Poly-Cath Red Polymer Urethral Catheter is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Medline Industries, Inc.. The 510(k) number is K183335.

When did Medline Poly-Cath Red Polymer Urethral Catheter receive FDA 510(k) clearance?

Medline Poly-Cath Red Polymer Urethral Catheter received FDA 510(k) clearance on 2019-06-12, under 510(k) number K183335.

Who is the listed applicant for Medline Poly-Cath Red Polymer Urethral Catheter?

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

What is the FDA product code for Medline Poly-Cath Red Polymer Urethral Catheter?

The FDA product code for Medline Poly-Cath Red Polymer Urethral Catheter is GBM.

Related Clinical Trials

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.

NCT07613892Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure AdhesivesCOMPLETEDNCT07734220Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.COMPLETED

Other records listing Medline Industries, Inc. as applicant

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.

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating SystemK213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeK212911Konig Mogen ClampK220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

View all 74 devices →

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.

↑