510(k) Report

FDA applicant

Interlace Medical, Inc.

Farmingham, MA7 decisions2008–20110 recalls

FDA records 7 decisions for Interlace Medical, Inc. (Farmingham, MA) from 2008 to 2011: 7 510(k) clearances. Most are in product codes HIH (Hysteroscope (And Accessories)) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 14 predicates, 5 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 Interlace Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 22009: 22010: 22011: 1
2008high 2 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Interlace Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Interlace Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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