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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Conway Stuart Medical, Inc. · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
161 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K000245CSM STRETTA SYSTEMConway Stuart Medical, Inc.2000-04-18820
K000170SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000Conway Stuart Medical, Inc.2000-02-14270
K992542TUBULAR ELECTRODE DEVICEConway Stuart Medical, Inc.1999-10-27890
K991529CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL Conway Stuart Medical, Inc.1999-09-141340
K990724CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIESConway Stuart Medical, Inc.1999-08-131610
K991291STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATIONConway Stuart Medical, Inc.1999-07-14900
K983986CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATORConway Stuart Medical, Inc.1999-03-231340
K983116ELECTROSURGICAL INFLATABLE BASKET ELECTRODESConway Stuart Medical, Inc.1998-12-03900
K983415DELIVERY SHEATHConway Stuart Medical, Inc.1998-12-01630
K981589ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELEConway Stuart Medical, Inc.1998-07-30870

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda