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FDA 510(k)

MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM

K-Number: K091107 · 2009-05-01

ApplicantHemostatix Medical Technologies, LLC
Decision Date2009-05-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemostatix Medical Technologies, LLC. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K091107. 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 MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM?

MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Hemostatix Medical Technologies, LLC. The 510(k) number is K091107.

When did MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM receive FDA 510(k) clearance?

MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM received FDA 510(k) clearance on 2009-05-01, under 510(k) number K091107.

Who is the listed applicant for MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM?

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

What is the FDA product code for MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM?

The FDA product code for MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM is GEI.

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Other records listing Hemostatix Medical Technologies, LLC 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.

K183009HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES

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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.

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