510(k) Report

FDA applicant

Suturtek Incorporated

Acton, MA4 decisions2003–20080 recalls

FDA records 4 decisions for Suturtek Incorporated (Acton, MA) from 2003 to 2008: 4 510(k) clearances. Most are in product codes GAQ (Suture, Nonabsorbable, Steel, Monofilament And…) and GAL (Suture, Absorbable, Natural). Its devices cite 7 predicates, 2 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Suturtek Incorporated 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?

  • GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile3decisions
  • GALSuture, Absorbable, Natural1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated · 20071cites it
  • K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 20031cites it
  • K030227Suturtek Fastclose Suturing DeviceSuturtek Incorporated · 20031cites it

What has FDA decided for it lately?

  • K082828Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated · 2008
  • K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated · 2007
  • K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003
  • K030227Suturtek Fastclose Suturing DeviceSuturtek Incorporated · 2003

All 4 as Suturtek Incorporated →