FDA 510(k)

SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200

K-Number: K982717 · 1998-11-02

ApplicantSomnus Medical Technologies, Inc.

Decision Date1998-11-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 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 1998-11-02 under 510(k) number K982717. 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 SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200?

SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 is a medical device that received FDA 510(k) clearance on 1998-11-02. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K982717.

When did SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 receive FDA 510(k) clearance?

SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 received FDA 510(k) clearance on 1998-11-02, under 510(k) number K982717.

Who is the listed applicant for SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200?

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 SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200?

The FDA product code for SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 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 K973701SOMNUS TISSUE COAGULATING ELECTRODE K970837SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE K970838SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE 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.