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

Sunnyvale, CA, US

Conway Stuart Medical, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 10 510(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
10
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 10 510(k) clearances for Conway Stuart Medical, Inc. between 1998 and 2000. The busiest year on record is 1999, with 5. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for Conway Stuart Medical, Inc., by decision year
YearClearances
19983
19995
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K000245CSM STRETTA SYSTEMGEISubstantially Equivalent
K000170SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000GEISubstantially Equivalent
K992542TUBULAR ELECTRODE DEVICEGEISubstantially Equivalent
K991529CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400GEISubstantially Equivalent
K990724CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIESGCJSubstantially Equivalent
K991291STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATIONGEISubstantially Equivalent
K983986CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATORGEISubstantially Equivalent
K983116ELECTROSURGICAL INFLATABLE BASKET ELECTRODESGEISubstantially Equivalent
K983415DELIVERY SHEATHFEDSubstantially Equivalent
K981589ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODESGEISubstantially 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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