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FDA 510(k)

STERILE 100% SILICONE FOLEY CATHETER

K-Number: K780675 · 1978-05-09

ApplicantMedline Industries, Inc.
Decision Date1978-05-09
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE 100% SILICONE FOLEY 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 1978-05-09 under 510(k) number K780675. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE 100% SILICONE FOLEY CATHETER?

STERILE 100% SILICONE FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1978-05-09. The listed applicant is Medline Industries, Inc.. The 510(k) number is K780675.

When did STERILE 100% SILICONE FOLEY CATHETER receive FDA 510(k) clearance?

STERILE 100% SILICONE FOLEY CATHETER received FDA 510(k) clearance on 1978-05-09, under 510(k) number K780675.

Who is the listed applicant for STERILE 100% SILICONE FOLEY 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 STERILE 100% SILICONE FOLEY CATHETER?

The FDA product code for STERILE 100% SILICONE FOLEY CATHETER is KOD.

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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