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FDA 510(k)

AMSURE BLADDER IRRIGATION SET

K-Number: K070873 · 2007-12-19

ApplicantAmsino Intl., Inc.
Decision Date2007-12-19
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSURE BLADDER IRRIGATION SET 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 2007-12-19 under 510(k) number K070873. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSURE BLADDER IRRIGATION SET?

AMSURE BLADDER IRRIGATION SET is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Amsino Intl., Inc.. The 510(k) number is K070873.

When did AMSURE BLADDER IRRIGATION SET receive FDA 510(k) clearance?

AMSURE BLADDER IRRIGATION SET received FDA 510(k) clearance on 2007-12-19, under 510(k) number K070873.

Who is the listed applicant for AMSURE BLADDER IRRIGATION SET?

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 AMSURE BLADDER IRRIGATION SET?

The FDA product code for AMSURE BLADDER IRRIGATION SET is LJH.

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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.

K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEK974042AMSURE CLEANSING ENEMA SETK973107AMSINO I.V. ADMINISTRATION SETK973199AMSINO SUCTION CATHETERK971929AMSINO URINARY LEG BAGK964745AMSINO URINARY DRAINAGE BAG

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Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLCK042457URO PROW.O.M. World of Medicine AG

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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