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FDA 510(k)

UROLOGICAL CATHETERS

K-Number: K810281 · 1981-02-25

ApplicantLatex Ind., Inc.
Decision Date1981-02-25
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGICAL CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Latex Ind., Inc.. It received FDA 510(k) clearance on 1981-02-25 under 510(k) number K810281. 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 UROLOGICAL CATHETERS?

UROLOGICAL CATHETERS is a medical device that received FDA 510(k) clearance on 1981-02-25. The listed applicant is Latex Ind., Inc.. The 510(k) number is K810281.

When did UROLOGICAL CATHETERS receive FDA 510(k) clearance?

UROLOGICAL CATHETERS received FDA 510(k) clearance on 1981-02-25, under 510(k) number K810281.

Who is the listed applicant for UROLOGICAL CATHETERS?

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

What is the FDA product code for UROLOGICAL CATHETERS?

The FDA product code for UROLOGICAL CATHETERS is KOD.

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.

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Other records listing Latex Ind., 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.

K812058AKRON URINARY DRAINAGE BATK791674BLADDER RETENTION CATHETERIZATION TRAYK781751CATHETER, AKRON FOLEY TEFLONK781433AKRON MALE EXTERNAL CATHETERK772277BLADDER RETENTION-CATHETHERIZATIONTRAYK772341BLADDER KIT - 734000

View all 14 devices →

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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