FDA 510(k)

INSERTEASE

K-Number: K092829 · 2009-12-02

Decision Date2009-12-02

Product CodeOOW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

INSERTEASE is the device name listed in this FDA 510(k) record. The listed applicant is Christcot Medical Company. It received FDA 510(k) clearance on 2009-12-02 under 510(k) number K092829. The device is classified under product code OOW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSERTEASE?

INSERTEASE is a medical device that received FDA 510(k) clearance on 2009-12-02. The listed applicant is Christcot Medical Company. The 510(k) number is K092829.

When did INSERTEASE receive FDA 510(k) clearance?

INSERTEASE received FDA 510(k) clearance on 2009-12-02, under 510(k) number K092829.

Who is the listed applicant for INSERTEASE?

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

What is the FDA product code for INSERTEASE?

The FDA product code for INSERTEASE is OOW.

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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.