FDA applicant

Origami Surgical, LLC

Madison, NJ7 decisions2013–20230 recalls

FDA records 7 decisions for Origami Surgical, LLC (Madison, NJ) from 2013 to 2023: 7 510(k) clearances. Most are in product codes GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid) and NBY (Suture, Surgical, Nonabsorbable, Expanded…). Its devices cite 18 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Origami Surgical Inc .”, “Origami Surgical”.

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 Origami Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013high 2 (2021) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Origami Surgical, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Origami Surgical, LLC’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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Origami Surgical, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?