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FDA 510(k)

TOUCHLESS HOME-CATH

K-Number: K812281 · 1981-10-13

ApplicantDiamed Division Ill. Tool Works, Inc.
Decision Date1981-10-13
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TOUCHLESS HOME-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Diamed Division Ill. Tool Works, Inc.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812281. 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 TOUCHLESS HOME-CATH?

TOUCHLESS HOME-CATH is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Diamed Division Ill. Tool Works, Inc.. The 510(k) number is K812281.

When did TOUCHLESS HOME-CATH receive FDA 510(k) clearance?

TOUCHLESS HOME-CATH received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812281.

Who is the listed applicant for TOUCHLESS HOME-CATH?

The FDA 510(k) record lists Diamed Division Ill. Tool Works, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOUCHLESS HOME-CATH?

The FDA product code for TOUCHLESS HOME-CATH is KOD.

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Other records listing Diamed Division Ill. Tool Works, 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.

K854953DIAMED MODELS 600, 900, 960, 964K823450FEMALE EXTERNAL URINARY APPLIANCEK802664URINARY DRAINAGE UNTK802665TOUCHLESS CLEAN-CATHK790728TOUCHLESS TM FOLEY CATHETER KITK760897STERILE URETHRAL CATHETER KIT

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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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