Endoform Reconstructive Template— 510(k) K153632

Name: FDA 510(k) clearance K153632
Creator: U.S. Food and Drug Administration
Published: 2016-06-16

Substantially Equivalent

Aroa Biosurgery Limited (Formerly Mesynthes Limited)

FDA 510(k) clearance K153632 for Endoform Reconstructive Template, Substantially Equivalent on 2016-06-16. Applicant: Aroa Biosurgery Limited (Formerly Mesynthes Limited). Device class: 2.

Clearance details

Applicant: Aroa Biosurgery Limited (Formerly Mesynthes Limited)
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2015-12-18
Decision date: 2016-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

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K153633 — Endoform Reconstructive Template2016-03-15

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.