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FDA 510(k)

UROMED PATCH

K-Number: K974600 · 1998-03-31

ApplicantUromed Corp.
Decision Date1998-03-31
Product CodeMNG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROMED PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Uromed Corp.. It received FDA 510(k) clearance on 1998-03-31 under 510(k) number K974600. The device is classified under product code MNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROMED PATCH?

UROMED PATCH is a medical device that received FDA 510(k) clearance on 1998-03-31. The listed applicant is Uromed Corp.. The 510(k) number is K974600.

When did UROMED PATCH receive FDA 510(k) clearance?

UROMED PATCH received FDA 510(k) clearance on 1998-03-31, under 510(k) number K974600.

Who is the listed applicant for UROMED PATCH?

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

What is the FDA product code for UROMED PATCH?

The FDA product code for UROMED PATCH is MNG.

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Other records listing Uromed Corp. 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.

K010213MODIFICATION TO CAVERMAP SURGICAL AIDK010098MODIFICATION TO CAVERMAP SURGICAL AIDK000507CAVERMAP SURGICAL AIDK993436CAVERMAP SURGICAL AIDK982226UROMED BRACHYTHERAPHY IODINE-125 SOURCESK980717UROMED SLING KIT

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Related Devices (Code: MNG)

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.

K010365ORTHO CONTROL FEMALE URINARY CONTROL DEVICEPersonal Products Co.K983164RESTORE (AKA RE/STOR)Nebl, Inc.K974645FEMASSIST FLEXIBLEInsight Medical Corp.K971359RESTORE (A.K.A. CAPSURE)Nebl, Inc.K963858FEMASSIST URINARY DEVICEInsight Medical Corp.K954215MINIGUARDAdvanced Surgical Intervention, 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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