FDA applicant

Safepath Medical, Inc.

Amesbury, MA2 decisions2018–20240 recalls

FDA records 2 decisions for Safepath Medical, Inc. (Amesbury, MA) from 2018 to 2024: 2 510(k) clearances. All are in product code GAP (Suture, Nonabsorbable, Silk). Its devices cite 5 predicates, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Safepath Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Safepath Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safepath Medical, Inc.’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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Safepath Medical, Inc.

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?