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FDA 510(k)

FEMASSIST URINARY DEVICE

K-Number: K963858 · 1997-10-21

ApplicantInsight Medical Corp.
Decision Date1997-10-21
Product CodeMNG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMASSIST URINARY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Insight Medical Corp.. It received FDA 510(k) clearance on 1997-10-21 under 510(k) number K963858. 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 FEMASSIST URINARY DEVICE?

FEMASSIST URINARY DEVICE is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Insight Medical Corp.. The 510(k) number is K963858.

When did FEMASSIST URINARY DEVICE receive FDA 510(k) clearance?

FEMASSIST URINARY DEVICE received FDA 510(k) clearance on 1997-10-21, under 510(k) number K963858.

Who is the listed applicant for FEMASSIST URINARY DEVICE?

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

What is the FDA product code for FEMASSIST URINARY DEVICE?

The FDA product code for FEMASSIST URINARY DEVICE is MNG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Insight Medical 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.

K974645FEMASSIST FLEXIBLEK932533SMARTSCOPE

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.K974600UROMED PATCHUromed Corp.K974645FEMASSIST FLEXIBLEInsight Medical Corp.K971359RESTORE (A.K.A. CAPSURE)Nebl, Inc.K954215MINIGUARDAdvanced Surgical Intervention, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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