Medical Device Manufacturer · US , Sunnyvale , CA

Somnus Medical Technologies, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1996
16
Total
16
Cleared
0
Denied

FDA 510(k) Regulatory Record - Somnus Medical Technologies, Inc. General & Plastic Surgery

16 devices
1-16 of 16
Cleared May 30, 2000
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR...
K000720 · GEI
General & Plastic Surgery · 88d
Cleared May 16, 2000
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
K001438 · GEI
General & Plastic Surgery · 8d
Cleared Mar 17, 2000
ELECTROSURGICAL GENERATOR, MODEL S1
K000501 · GEI
General & Plastic Surgery · 31d
Cleared Nov 02, 1998
SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
K982717 · GEI
General & Plastic Surgery · 90d
Cleared Jan 30, 1998
SOMNUS TISSUE COAGULATING ELECTRODE
K973701 · GEI
General & Plastic Surgery · 123d
Cleared Jan 09, 1998
SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE
K970837 · GEI
General & Plastic Surgery · 308d
Cleared Jan 09, 1998
SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE
K970838 · GEI
General & Plastic Surgery · 308d
Cleared Dec 19, 1997
SOMNOPLASTY SYSTEM
K973618 · GEI
General & Plastic Surgery · 87d
Cleared Jul 17, 1997
SOMNOPLASTY SYSTEM
K971450 · GEI
General & Plastic Surgery · 87d
Cleared Jun 24, 1997
SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR
K971711 · GEI
General & Plastic Surgery · 47d
Cleared Jun 18, 1997
BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL
K970809 · GEI
General & Plastic Surgery · 105d
Cleared Apr 09, 1997
SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
K970576 · GEI
General & Plastic Surgery · 55d
Cleared Dec 16, 1996
SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350
K963884 · GEI
General & Plastic Surgery · 81d
Cleared Oct 23, 1996
SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
K963772 · GEI
General & Plastic Surgery · 34d
Cleared Jul 10, 1996
SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
K961133 · GEI
General & Plastic Surgery · 111d
Cleared May 22, 1996
SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE
K961132 · GEI
General & Plastic Surgery · 62d
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