DeviceClearance

CanGaroo Neuro Envelope (4 models)— 510(k) K182255

Substantially Equivalent

Aziyo Biologics, Inc.

FDA 510(k) clearance K182255 for CanGaroo Neuro Envelope (4 models), Substantially Equivalent on 2018-11-15. Applicant: Aziyo Biologics, Inc.. Device class: 2.

Clearance details

Device name as filed
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
Applicant
Aziyo Biologics, Inc.
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
Traditional
Location
Roswell, GA, US
Download summary PDFView on FDA.gov ↗

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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 K182255

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 K182255.

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