Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device— 510(k) K220091

Name: FDA 510(k) clearance K220091
Creator: U.S. Food and Drug Administration
Published: 2022-08-26

Substantially Equivalent

Xiros, Ltd.

FDA 510(k) clearance K220091 for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, Substantially Equivalent on 2022-08-26. Applicant: Xiros, Ltd.. Device class: 2.

Clearance details

Applicant: Xiros, Ltd.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2022-01-12
Decision date: 2022-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTL

view all

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
K250869 — Parietene Macroporous Mesh (PPM5050 )2025-04-23

More clearances from Xiros, Ltd.

view all

K230671 — Pitch PaSoft Tissue Reinforcement Device2023-05-31
K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device2022-12-27
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.