Cleared Traditional

Pitch-Patchs

K211563 · Xiros, Ltd. · General & Plastic Surgery
Aug 2021
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K211563 is an FDA 510(k) clearance for the Pitch-Patchs, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on August 13, 2021, 85 days after receiving the submission on May 20, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K211563 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2021
Decision Date August 13, 2021
Days to Decision 85 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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