FDA applicant

Henke Sass Wolf of America, Inc.

Southbridge, MA9 decisions1994–20080 recalls

FDA records 9 decisions for Henke Sass Wolf of America, Inc. (Southbridge, MA) from 1994 to 2008: 9 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HRX (Arthroscope). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Henke Sass Wolf of America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Henke Sass Wolf of America, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Henke Sass Wolf of America, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Henke”

FDA records each applicant name separately; these may or may not be the same firm.

Henke-Sass, Wolf GmbH 6

Henke Sass Wolf of America, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Henke”