510(k) Report

FDA applicant

Aros Surgical Instruments Corp.

Irvine, CA2 decisions2004–20160 recalls

FDA records 2 decisions for Aros Surgical Instruments Corp. (Irvine, CA) from 2004 to 2016: 2 510(k) clearances. Most are in product codes GAR (Suture, Nonabsorbable, Synthetic, Polyamide) and DXC (Clamp, Vascular). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aros Surgical Instruments Corporation”.

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 Aros Surgical Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aros Surgical Instruments Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aros Surgical Instruments Corp.’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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Which product codes does it file in?

  • GARSuture, Nonabsorbable, Synthetic, Polyamide1decision
  • DXCClamp, Vascular1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K161315Vein Clamps, Artery ClampsAros Surgical Instruments Corporation · 20161cites it

What has FDA decided for it lately?

  • K161315Vein Clamps, Artery ClampsAros Surgical Instruments Corporation · 2016
  • K042367Nylon Threaded NeedleAros Surgical Instruments Corp. · 2004

The one decision as Aros Surgical Instruments Corp. →The one decision as Aros Surgical Instruments Corporation →