FDA 510(k)

ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD

K-Number: K934985 · 1994-02-17

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1994-02-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1994-02-17 under 510(k) number K934985. 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 ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD?

ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K934985.

When did ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD receive FDA 510(k) clearance?

ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD received FDA 510(k) clearance on 1994-02-17, under 510(k) number K934985.

Who is the listed applicant for ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD?

The FDA product code for ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD 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.