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FDA 510(k)

FEMALE EXTERNAL URINARY APPLIANCE

K-Number: K823450 · 1982-12-28

ApplicantDiamed Division Ill. Tool Works, Inc.
Decision Date1982-12-28
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMALE EXTERNAL URINARY APPLIANCE 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 1982-12-28 under 510(k) number K823450. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMALE EXTERNAL URINARY APPLIANCE?

FEMALE EXTERNAL URINARY APPLIANCE is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Diamed Division Ill. Tool Works, Inc.. The 510(k) number is K823450.

When did FEMALE EXTERNAL URINARY APPLIANCE receive FDA 510(k) clearance?

FEMALE EXTERNAL URINARY APPLIANCE received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823450.

Who is the listed applicant for FEMALE EXTERNAL URINARY APPLIANCE?

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 FEMALE EXTERNAL URINARY APPLIANCE?

The FDA product code for FEMALE EXTERNAL URINARY APPLIANCE is KNX.

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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, 964K812281TOUCHLESS HOME-CATHK802664URINARY DRAINAGE UNTK802665TOUCHLESS CLEAN-CATHK790728TOUCHLESS TM FOLEY CATHETER KITK760897STERILE URETHRAL CATHETER KIT

View all 7 devices →

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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