FDA applicant

Netoptix Corp.

North Attleboro, MA4 decisions1997–19980 recalls

FDA records 4 decisions for Netoptix Corp. (North Attleboro, MA) from 1997 to 1998: 4 510(k) clearances. Most are in product codes HIH (Hysteroscope (And Accessories)) and HEX (Colposcope (And Colpomicroscope)). Its devices cite 12 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Netoptix Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Netoptix Corp.

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?