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FDA 510(k)

SOMNOPLASTY SYSTEM

K-Number: K971450 · 1997-07-17

ApplicantSomnus Medical Technologies, Inc.
Decision Date1997-07-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOMNOPLASTY SYSTEM 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 1997-07-17 under 510(k) number K971450. 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?

SOMNOPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K971450.

When did SOMNOPLASTY SYSTEM receive FDA 510(k) clearance?

SOMNOPLASTY SYSTEM received FDA 510(k) clearance on 1997-07-17, under 510(k) number K971450.

Who is the listed applicant for SOMNOPLASTY SYSTEM?

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?

The FDA product code for SOMNOPLASTY SYSTEM 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 GENERATORK000501ELECTROSURGICAL GENERATOR, MODEL S1K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200K973701SOMNUS TISSUE COAGULATING ELECTRODEK970838SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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