FDA 510(k)

KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES

K-Number: K944796 · 1994-11-02

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1994-11-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES 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 1994-11-02 under 510(k) number K944796. 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 KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES?

KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K944796.

When did KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES receive FDA 510(k) clearance?

KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES received FDA 510(k) clearance on 1994-11-02, under 510(k) number K944796.

Who is the listed applicant for KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES?

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 KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES?

The FDA product code for KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES is GEI.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

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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.