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FDA 510(k)

URI-SURE

K-Number: K852619 · 1985-08-27

ApplicantAshai Co. , Ltd.
Decision Date1985-08-27
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URI-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Ashai Co. , Ltd.. It received FDA 510(k) clearance on 1985-08-27 under 510(k) number K852619. 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 URI-SURE?

URI-SURE is a medical device that received FDA 510(k) clearance on 1985-08-27. The listed applicant is Ashai Co. , Ltd.. The 510(k) number is K852619.

When did URI-SURE receive FDA 510(k) clearance?

URI-SURE received FDA 510(k) clearance on 1985-08-27, under 510(k) number K852619.

Who is the listed applicant for URI-SURE?

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

What is the FDA product code for URI-SURE?

The FDA product code for URI-SURE is KNX.

Other records listing Ashai Co. , Ltd. 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.

K870428AEROSOL ONE, NEBULIZER PUMPK852622AEROSOL ONEK852620SAFE.N.SUREK852627MAXI-NEBK852629AERO-MASK TWOK852625OXY-TUBE

View all 12 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.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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