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

Wilson Greatbatch Technologies, Inc. — Predicate Candidate Screening

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

200 daysmedian FDA review time
394 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971374GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPEWilson Greatbatch Technologies, Inc.1998-05-133940
K971377GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPEWilson Greatbatch Technologies, Inc.1998-04-303810
K972280GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATIWilson Greatbatch Technologies, Inc.1997-12-111760
K971781GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JWilson Greatbatch Technologies, Inc.1997-11-211910
K970619GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPWilson Greatbatch Technologies, Inc.1997-11-192740
K971375GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPEWilson Greatbatch Technologies, Inc.1997-10-312000
K954649WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAPWilson Greatbatch Technologies, Inc.1995-12-22730
K950063WGL ENDOSCOPIC GRASPER*Wilson Greatbatch Technologies, Inc.1995-01-27210
K942168WGL ENDOSCOPIC GRASPERWilson Greatbatch Technologies, Inc.1994-12-132230

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