510(k) Report

FDA applicant

Gordian Surgical, Ltd.

Misgav Business Park, IL3 decisions2016–20251 recall

FDA records 3 decisions for Gordian Surgical, Ltd. (Misgav Business Park, IL) from 2016 to 2025: 3 510(k) clearances. All are in product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. 1 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 Gordian Surgical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12025: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2016high 1 (2020) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Gordian Surgical, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gordian Surgical, Ltd.’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?

  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 28 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K171494TroClose1200, TroClose1200 CannulaGordian Surgical, Ltd. · 20171cites it
  • K160564TroClose1200Gordian Surgical, Ltd. · 20161cites it

What has FDA decided for it lately?

  • K253620TroClose 1200Gordian Surgical, Ltd. · 2025
  • K171494TroClose1200, TroClose1200 CannulaGordian Surgical, Ltd. · 20171 recall
  • K160564TroClose1200Gordian Surgical, Ltd. · 20161 recall

All 3 as Gordian Surgical, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K160564TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and…Sep 22, 2020Class II