510(k) Report

FDA applicant

Wisap/U.S.A.

Munchen,, DE1 decision1995–19950 recalls

FDA records 1 decision for Wisap/U.S.A. (Munchen,, DE) in 1995: 1 510(k) clearance. All are in product code 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/U.S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wisap/U.S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wisap/U.S.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wisap/U.S.A.’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

Which product codes does it file in?

  • HIFInsufflator, Laparoscopic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K941438OP-Pneu Electronic CO2Wisap/U.S.A. · 19951cites it

What has FDA decided for it lately?

  • K941438OP-Pneu Electronic CO2Wisap/U.S.A. · 1995

The one decision as Wisap/U.S.A. →

Other applicant names beginning “Wisap/U.S.A.”

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

Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh 9