FDA 510(k)

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

K-Number: K093079 · 2010-08-02

Decision Date2010-08-02

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U is the device name listed in this FDA 510(k) record. The listed applicant is Hobbs Medical, Inc.. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K093079. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U?

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Hobbs Medical, Inc.. The 510(k) number is K093079.

When did TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U receive FDA 510(k) clearance?

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U received FDA 510(k) clearance on 2010-08-02, under 510(k) number K093079.

Who is the listed applicant for TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U?

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

What is the FDA product code for TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U?

The FDA product code for TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U is KNS.

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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.