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FDA 510(k)

FEMASSIST FLEXIBLE

K-Number: K974645 · 1998-02-12

ApplicantInsight Medical Corp.
Decision Date1998-02-12
Product CodeMNG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMASSIST FLEXIBLE 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 1998-02-12 under 510(k) number K974645. 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 FLEXIBLE?

FEMASSIST FLEXIBLE is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Insight Medical Corp.. The 510(k) number is K974645.

When did FEMASSIST FLEXIBLE receive FDA 510(k) clearance?

FEMASSIST FLEXIBLE received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974645.

Who is the listed applicant for FEMASSIST FLEXIBLE?

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 FLEXIBLE?

The FDA product code for FEMASSIST FLEXIBLE 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.

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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.

K963858FEMASSIST URINARY DEVICEK932533SMARTSCOPE

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.K971359RESTORE (A.K.A. CAPSURE)Nebl, Inc.K963858FEMASSIST URINARY DEVICEInsight Medical Corp.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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