FDA applicant

General Project S.R.L.

North Reading, MA6 decisions2001–20160 recalls

FDA records 6 decisions for General Project S.R.L. (North Reading, MA) from 2001 to 2016: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and IMI (Ultrasonic Diathermy For Use In Applying…). Its devices cite 17 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “General Project”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided General Project S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — General Project S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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General Project S.R.L.

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?