FDA 510(k)

SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)

K-Number: K970576 · 1997-04-09

ApplicantSomnus Medical Technologies, Inc.

Decision Date1997-04-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) 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 1997-04-09 under 510(k) number K970576. 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 615 ELECTROSURGICAL GENERATOR(MODEL 615)?

SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K970576.

When did SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) receive FDA 510(k) clearance?

SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) received FDA 510(k) clearance on 1997-04-09, under 510(k) number K970576.

Who is the listed applicant for SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)?

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 615 ELECTROSURGICAL GENERATOR(MODEL 615)?

The FDA product code for SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) 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 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.