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FDA 510(k)

WELCON HUE-VU URINARY DRAINAGE BAG

K-Number: K971764 · 1997-07-29

ApplicantWelcon, Inc.
Decision Date1997-07-29
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WELCON HUE-VU URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K971764. 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 WELCON HUE-VU URINARY DRAINAGE BAG?

WELCON HUE-VU URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Welcon, Inc.. The 510(k) number is K971764.

When did WELCON HUE-VU URINARY DRAINAGE BAG receive FDA 510(k) clearance?

WELCON HUE-VU URINARY DRAINAGE BAG received FDA 510(k) clearance on 1997-07-29, under 510(k) number K971764.

Who is the listed applicant for WELCON HUE-VU URINARY DRAINAGE BAG?

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

What is the FDA product code for WELCON HUE-VU URINARY DRAINAGE BAG?

The FDA product code for WELCON HUE-VU URINARY DRAINAGE BAG is KNX.

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Other records listing Welcon, 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.

K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONK973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONK912869WOMEN AND INFANT'S DELIVERY PACKK904158ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAYK894397WELCON LIGHT HANDLEK830359STERILE CATHERIZATION PROCEDURE TRAYS

View all 8 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.K964690LIBERTY VALVECleveland Medical Devices, 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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