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FDA 510(k)

HEMO STATIC/ESU SCALPEL SYSTEM

K-Number: K842622 · 1984-10-23

ApplicantOximetrix, Inc.
Decision Date1984-10-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEMO STATIC/ESU SCALPEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1984-10-23 under 510(k) number K842622. 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 HEMO STATIC/ESU SCALPEL SYSTEM?

HEMO STATIC/ESU SCALPEL SYSTEM is a medical device that received FDA 510(k) clearance on 1984-10-23. The listed applicant is Oximetrix, Inc.. The 510(k) number is K842622.

When did HEMO STATIC/ESU SCALPEL SYSTEM receive FDA 510(k) clearance?

HEMO STATIC/ESU SCALPEL SYSTEM received FDA 510(k) clearance on 1984-10-23, under 510(k) number K842622.

Who is the listed applicant for HEMO STATIC/ESU SCALPEL SYSTEM?

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

What is the FDA product code for HEMO STATIC/ESU SCALPEL SYSTEM?

The FDA product code for HEMO STATIC/ESU SCALPEL SYSTEM is 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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