Pitch PaSoft Tissue Reinforcement Device— 510(k) K230671

Name: FDA 510(k) clearance K230671
Creator: U.S. Food and Drug Administration
Published: 2023-05-31

Substantially Equivalent

Xiros, Ltd.

FDA 510(k) clearance K230671 for Pitch PaSoft Tissue Reinforcement Device, Substantially Equivalent on 2023-05-31. Applicant: Xiros, Ltd.. Device class: 2.

Clearance details

Applicant: Xiros, Ltd.
Product code: Product code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2023-03-10
Decision date: 2023-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

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K260474 — Liora Monofilament Scaffold2026-09-28
K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)2026-05-21
K253125 — Parietene Flat Sheet Mesh2025-10-24
K251955 — Onflex Mesh2025-07-24
K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped2025-06-12

More clearances from Xiros, Ltd.

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K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device2022-12-27
K220091 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device2022-08-26
K220906 — SECURE-LOCK2022-07-22
K211563 — Pitch-Patchs2021-08-13
K191053 — Xtreme-Loop2019-07-17

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.