Cleared Traditional

Pitch PaSoft Tissue Reinforcement Device

K230671 · Xiros, Ltd. · General & Plastic Surgery
May 2023
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K230671 is an FDA 510(k) clearance for the Pitch PaSoft Tissue Reinforcement Device, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on May 31, 2023, 82 days after receiving the submission on March 10, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K230671 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2023
Decision Date May 31, 2023
Days to Decision 82 days
Submission Type Traditional
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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