FDA applicant

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

Sauerlach, DE9 decisions1995–20030 recalls

FDA records 9 decisions for Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (Sauerlach, DE) from 1995 to 2003: 9 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and HIF (Insufflator, Laparoscopic). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wisap Gesellschaft Fur Wissenschaftl.…’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 “Wisap”

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

Wisap/U.S.A. 1

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Wisap”