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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 a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-06-12 under approval 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. It is manufactured by Medline Industries, Inc.. The 510(k) number is K183335.

When was Medline Poly-Cath Red Polymer Urethral Catheter approved by the FDA?

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

What company makes Medline Poly-Cath Red Polymer Urethral Catheter?

Medline Poly-Cath Red Polymer Urethral Catheter is manufactured by Medline Industries, Inc..

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.

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Related Devices (Code: GBM)

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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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