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FDA 510(k)

SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE

K-Number: K961133 · 1996-07-10

ApplicantSomnus Medical Technologies, Inc.
Decision Date1996-07-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE 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 1996-07-10 under 510(k) number K961133. 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 MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Somnus Medical Technologies, Inc.. The 510(k) number is K961133.

When did SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE receive FDA 510(k) clearance?

SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961133.

Who is the listed applicant for SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

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 MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE?

The FDA product code for SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE 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 ELECTRODEK970837SOMNUS 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.

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