DeviceClearance

Endoform Reconstructive Template— 510(k) K153633

Substantially Equivalent

Aroa Biosurgery Limited (Formerly Mesynthes Limited)

FDA 510(k) clearance K153633 for Endoform Reconstructive Template, Substantially Equivalent on 2016-03-15. Applicant: Aroa Biosurgery Limited (Formerly Mesynthes Limited). Device class: 2.

Clearance details

Applicant
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
Product code
Code FTM
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Auckland, NZ
Download summary PDFView on FDA.gov ↗

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More clearances from Aroa Biosurgery Limited (Formerly Mesynthes Limited)

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Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

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

Recalls naming K153633

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153633.

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