510(k) Report

FDA applicant

Intact Medical Corporation

Framingham, MA4 decisions2006–20160 recalls

FDA records 4 decisions for Intact Medical Corporation (Framingham, MA) from 2006 to 2016: 4 510(k) clearances. All are in product code KNW (Instrument, Biopsy). Its devices cite 5 predicates, 4 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, gastroenterology and urology panel, where it files most

How often FDA has decided Intact Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12014: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intact Medical Corporation 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?

  • KNWInstrument, Biopsy4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 20062cite it
  • K152596Intact® Gen2 SystemIntact Medical Corporation · 20161cites it
  • K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 20081cites it
  • K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 20141cites it

What has FDA decided for it lately?

  • K152596Intact® Gen2 SystemIntact Medical Corporation · 2016
  • K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation · 2014
  • K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation · 2008
  • K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation · 2006

All 4 as Intact Medical Corporation →