Cleared Special

Bard? Mesh; Bard? Mesh Pre-Shaped

K251557 · Davol, Inc. · General & Plastic Surgery
Jun 2025
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K251557 is an FDA 510(k) clearance for the Bard? Mesh; Bard? Mesh Pre-Shaped, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Davol, Inc. (Warwick, US). The FDA issued a Cleared decision on June 12, 2025, 22 days after receiving the submission on May 21, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K251557 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2025
Decision Date June 12, 2025
Days to Decision 22 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTL — Mesh, Surgical, Polymeric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300

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