FDA 510(k)

HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM

K-Number: K033089 · 2004-02-05

Decision Date2004-02-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K033089. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM?

HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is Gyrus Ent LLC. The 510(k) number is K033089.

When did HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM receive FDA 510(k) clearance?

HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM received FDA 510(k) clearance on 2004-02-05, under 510(k) number K033089.

Who is the listed applicant for HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM?

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

What is the FDA product code for HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM?

The FDA product code for HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM is GEI.

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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.