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FDA 510(k)

ELECTROSURGICAL GENERATOR, MODEL S1

K-Number: K000501 · 2000-03-17

ApplicantSomnus Medical Technologies, Inc.
Decision Date2000-03-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL GENERATOR, MODEL S1 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 2000-03-17 under 510(k) number K000501. 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 ELECTROSURGICAL GENERATOR, MODEL S1?

ELECTROSURGICAL GENERATOR, MODEL S1 is a medical device that received FDA 510(k) clearance on 2000-03-17. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K000501.

When did ELECTROSURGICAL GENERATOR, MODEL S1 receive FDA 510(k) clearance?

ELECTROSURGICAL GENERATOR, MODEL S1 received FDA 510(k) clearance on 2000-03-17, under 510(k) number K000501.

Who is the listed applicant for ELECTROSURGICAL GENERATOR, MODEL S1?

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 ELECTROSURGICAL GENERATOR, MODEL S1?

The FDA product code for ELECTROSURGICAL GENERATOR, MODEL S1 is GEI.

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Other records listing Somnus Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000720SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLEK001438SOMNUS MODEL S2 ELECTROSURGICAL GENERATORK982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200K973701SOMNUS TISSUE COAGULATING ELECTRODEK970838SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODEK970837SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE

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Related Devices (Code: GEI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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