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FDA 510(k)

HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE

K-Number: K002021 · 2000-08-24

ApplicantGyrus Ent LLC
Decision Date2000-08-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE 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 2000-08-24 under 510(k) number K002021. 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 THERMAL SCALPEL SYSTEM - #12 BLADE?

HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Gyrus Ent LLC. The 510(k) number is K002021.

When did HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE receive FDA 510(k) clearance?

HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE received FDA 510(k) clearance on 2000-08-24, under 510(k) number K002021.

Who is the listed applicant for HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE?

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 THERMAL SCALPEL SYSTEM - #12 BLADE?

The FDA product code for HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE is GEI.

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Related Devices (Code: GEI)

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Official Source

View on FDA Database →

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

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