510(k) Report

FDA applicant

Insitu Systems

North Attleboro, MA1 decision2005–20050 recalls

FDA records 1 decision for Insitu Systems (North Attleboro, MA) in 2005: 1 510(k) clearance. All are in product code HEW (Culdoscope (And Accessories)). Its devices cite 2 predicates, 0 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Insitu Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Insitu Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Insitu Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HEWCuldoscope (And Accessories)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K051160ManipusealInsitu Systems · 2005

The one decision as Insitu Systems →