510(k) Report

FDA applicant

Sterylab S.R.L.

Mccordsville, IN1 decision2005–20050 recalls

FDA records 1 decision for Sterylab S.R.L. (Mccordsville, IN) in 2005: 1 510(k) clearance. All are in product code FCG (Biopsy Needle). Its devices cite 4 predicates, 0 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 Sterylab S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterylab S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sterylab S.R.L. 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?

  • FCGBiopsy Needle1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue BiopsySterylab S.R.L. · 20053cite it

What has FDA decided for it lately?

  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue BiopsySterylab S.R.L. · 2005

The one decision as Sterylab S.R.L. →