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FDA 510(k)

ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG

K-Number: K901320 · 1991-01-25

ApplicantEp Medical, Inc.
Decision Date1991-01-25
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Ep Medical, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K901320. 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 ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG?

ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Ep Medical, Inc.. The 510(k) number is K901320.

When did ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG receive FDA 510(k) clearance?

ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG received FDA 510(k) clearance on 1991-01-25, under 510(k) number K901320.

Who is the listed applicant for ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG?

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

What is the FDA product code for ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG?

The FDA product code for ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG is KNX.

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 Ep Medical, 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.

K935590EP MEDICAL, INC. EP-3 CLINICAL STIMULATORK933069MODEL EP-2 CLINICAL STIMULATOR

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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