FDA 510(k)

SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR

K-Number: K001438 · 2000-05-16

ApplicantSomnus Medical Technologies, Inc.

Decision Date2000-05-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR 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 2000-05-16 under 510(k) number K001438. 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 MODEL S2 ELECTROSURGICAL GENERATOR?

SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 2000-05-16. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K001438.

When did SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 2000-05-16, under 510(k) number K001438.

Who is the listed applicant for SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR?

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 MODEL S2 ELECTROSURGICAL GENERATOR?

The FDA product code for SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR 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 K000501ELECTROSURGICAL GENERATOR, MODEL S1 K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 K973701SOMNUS TISSUE COAGULATING ELECTRODE K970838SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE 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.