FDA applicant

Mle, Inc.

South Grafton, MA1 decision2002–20020 recalls

FDA records 1 decision for Mle, Inc. (South Grafton, MA) in 2002: 1 510(k) clearance. All are in product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). 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 Mle, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mle, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Mle, Inc.

Which product codes does it file in?

What has FDA decided for it lately?