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FDA 510(k)

FEMEX

K-Number: K812907 · 1981-11-02

ApplicantPromac
Decision Date1981-11-02
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMEX is the device name listed in this FDA 510(k) record. The listed applicant is Promac. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812907. 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 FEMEX?

FEMEX is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Promac. The 510(k) number is K812907.

When did FEMEX receive FDA 510(k) clearance?

FEMEX received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812907.

Who is the listed applicant for FEMEX?

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

What is the FDA product code for FEMEX?

The FDA product code for FEMEX is KNX.

Related Clinical Trials

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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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