Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Henke Sass Wolf of America, Inc. · Predicate Candidate Screening

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

58 daysmedian FDA review time
234 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEHenke Sass Wolf of America, Inc.2008-03-18190
K050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEHenke Sass Wolf of America, Inc.2005-03-24580
K030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEHenke Sass Wolf of America, Inc.2003-04-01360
K013611HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPEHenke Sass Wolf of America, Inc.2002-02-01880
K991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKEHenke Sass Wolf of America, Inc.1999-10-131610
K983067FINE-JECTHenke Sass Wolf of America, Inc.1998-10-30580
K981751SINUSCOPE AND ACCESSORIESHenke Sass Wolf of America, Inc.1998-08-13870
K962075HSW GMBH ARTHROSCOPEHenke Sass Wolf of America, Inc.1997-01-172340
K941541HSV LAPAROSCOPY SETHenke Sass Wolf of America, Inc.1994-05-16480

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