Atlas FDA

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

Henke-Sass, Wolf GmbH — Predicate Candidate Screening

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

213 daysmedian FDA review time
273 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173070HSW Resection InstrumentsHenke-Sass, Wolf GmbH2018-06-082520
K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mHenke-Sass, Wolf GmbH2017-12-072130
K101547HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)Henke-Sass, Wolf GmbH2010-11-221720
K952186HSW GMBH HYSTEROSCOPES & ACCESSORIESHenke-Sass, Wolf GmbH1996-02-062730
K943624ELMED PNEUMOPERITONEUM NEEDLESHenke-Sass, Wolf GmbH1994-08-10150
K941967HSW LAPAROSCOPE AND ACCESSORIESHenke-Sass, Wolf GmbH1994-05-16240

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