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FDA 510(k)

AMSINO URINARY LEG BAG

K-Number: K971929 · 1997-08-06

ApplicantAmsino Intl., Inc.
Decision Date1997-08-06
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSINO URINARY LEG BAG is the device name listed in this FDA 510(k) record. The listed applicant is Amsino Intl., Inc.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K971929. 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 AMSINO URINARY LEG BAG?

AMSINO URINARY LEG BAG is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Amsino Intl., Inc.. The 510(k) number is K971929.

When did AMSINO URINARY LEG BAG receive FDA 510(k) clearance?

AMSINO URINARY LEG BAG received FDA 510(k) clearance on 1997-08-06, under 510(k) number K971929.

Who is the listed applicant for AMSINO URINARY LEG BAG?

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

What is the FDA product code for AMSINO URINARY LEG BAG?

The FDA product code for AMSINO URINARY LEG 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 Amsino Intl., 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.

K070873AMSURE BLADDER IRRIGATION SETK992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEK974042AMSURE CLEANSING ENEMA SETK973107AMSINO I.V. ADMINISTRATION SETK973199AMSINO SUCTION CATHETERK964745AMSINO URINARY DRAINAGE BAG

View all 9 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.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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