510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Somnus Medical Technologies, Inc.

Sunnyvale, CA, US

Somnus Medical Technologies, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Somnus Medical Technologies, Inc. between 1996 and 2000. The busiest year on record is 1997, with 5. The most recent is 2000, with 3.

Clearances by year, as a table
510(k) clearance decisions for Somnus Medical Technologies, Inc., by decision year
YearClearances
19964
19975
19984
20003
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K000720SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLEGEISubstantially Equivalent
K001438SOMNUS MODEL S2 ELECTROSURGICAL GENERATORGEISubstantially Equivalent
K000501ELECTROSURGICAL GENERATOR, MODEL S1GEISubstantially Equivalent
K982717SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200GEISubstantially Equivalent
K973701SOMNUS TISSUE COAGULATING ELECTRODEGEISubstantially Equivalent
K970838SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODEGEISubstantially Equivalent
K970837SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODEGEISubstantially Equivalent
K973618SOMNOPLASTY SYSTEMGEISubstantially Equivalent
K971450SOMNOPLASTY SYSTEMGEISubstantially Equivalent
K971711SOMNUS MODEL 215 ELECTROSURGICAL GENERATORGEISubstantially Equivalent
K970809BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOLGEISubstantially Equivalent
K970576SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)GEISubstantially Equivalent
K963884SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350GEISubstantially Equivalent
K963772SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)GEISubstantially Equivalent
K961133SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODEGEISubstantially Equivalent
K961132SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODEGEISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain