510(k) Report

FDA applicant

Qrc Consulting

Hopkonton, MA1 decision2001–20010 recalls

FDA records 1 decision for Qrc Consulting (Hopkonton, MA) in 2001: 1 510(k) clearance. All are in product code GAL (Suture, Absorbable, Natural). 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 Qrc Consulting’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qrc Consulting since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qrc Consulting 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?

  • GALSuture, Absorbable, Natural1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K011105Suturtek Fastclose Fascia Closure DeviceQrc Consulting · 20014cite it

What has FDA decided for it lately?

  • K011105Suturtek Fastclose Fascia Closure DeviceQrc Consulting · 2001

The one decision as Qrc Consulting →