Atlas FDA

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

Gynecare Innovation Center · Predicate Candidate Screening

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

125 daysmedian FDA review time
206 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980393SOPRANO CRYO-THERAPY SYSTEMGynecare Innovation Center1998-05-01880
K971305FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEMGynecare Innovation Center1997-08-111250
K964441FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT EGynecare Innovation Center1997-03-281420
K964892FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)Gynecare Innovation Center1997-02-04600
K963872FEMRX MORCELLATOR SYSTEMGynecare Innovation Center1997-01-171130
K962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]Gynecare Innovation Center1996-09-16810
K954775FLO-STAT FLUID MONITORING SYSTEMGynecare Innovation Center1996-05-102060
K954648FEMRX OPERASTAR SYSTEMGynecare Innovation Center1996-03-141560

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