FDA 510(k)

CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O

K-Number: K103665 · 2011-02-16

Decision Date2011-02-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2011-02-16 under 510(k) number K103665. 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 CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O?

CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Conmed Corporation. The 510(k) number is K103665.

When did CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O receive FDA 510(k) clearance?

CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O received FDA 510(k) clearance on 2011-02-16, under 510(k) number K103665.

Who is the listed applicant for CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O?

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

What is the FDA product code for CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O?

The FDA product code for CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O 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.