FDA 510(k)

SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350

K-Number: K963884 · 1996-12-16

ApplicantSomnus Medical Technologies, Inc.

Decision Date1996-12-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 is the device name listed in this FDA 510(k) record. The listed applicant is Somnus Medical Technologies, Inc.. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K963884. 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 SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350?

SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K963884.

When did SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 receive FDA 510(k) clearance?

SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 received FDA 510(k) clearance on 1996-12-16, under 510(k) number K963884.

Who is the listed applicant for SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350?

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

What is the FDA product code for SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350?

The FDA product code for SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 is GEI.

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Other records listing Somnus Medical Technologies, Inc. as applicant

K000720SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE K001438SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR K000501ELECTROSURGICAL GENERATOR, MODEL S1 K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 K973701SOMNUS TISSUE COAGULATING ELECTRODE K970837SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE

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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.