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FDA 510(k)

URINARY CATHETERS #3400,3410 &3420

K-Number: K801784 · 1980-08-13

ApplicantThe Healthcare Group Laboratories, Inc.
Decision Date1980-08-13
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY CATHETERS #3400,3410 &3420 is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801784. 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 URINARY CATHETERS #3400,3410 &3420?

URINARY CATHETERS #3400,3410 &3420 is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K801784.

When did URINARY CATHETERS #3400,3410 &3420 receive FDA 510(k) clearance?

URINARY CATHETERS #3400,3410 &3420 received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801784.

Who is the listed applicant for URINARY CATHETERS #3400,3410 &3420?

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

What is the FDA product code for URINARY CATHETERS #3400,3410 &3420?

The FDA product code for URINARY CATHETERS #3400,3410 &3420 is KOD.

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Other records listing The Healthcare Group Laboratories, 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.

K850035EMPTY SOLUTION TRANSFER CONTAINERK842170EMPTY SOLUTION TRANSFER CONTAINERK842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYK840742RIGHT ATRIAL CATHETERK830299SOLUTION TRANSFER CONTAINERK822307ADHESIVE SPRAY #4050-4060

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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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