CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)— 510(k) K173242

Name: FDA 510(k) clearance K173242
Creator: U.S. Food and Drug Administration
Published: 2017-10-25

Substantially Equivalent

Aziyo Biologics, Inc.

FDA 510(k) clearance K173242 for CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), Substantially Equivalent on 2017-10-25. Applicant: Aziyo Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Aziyo Biologics, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2017-10-06
Decision date: 2017-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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K243595 — OviTex PRS (Long-Term Resorbable)2024-12-19
K233991 — CanGaroo RM Antibacterial Envelope2024-06-14
K241126 — OviTex PRS2024-05-22

More clearances from Aziyo Biologics, Inc.

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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, 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 →

Recalls naming K173242

K-number listed on FDA's recall record

Z-0040-2020 — CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.Class II·Terminated·AZIYO BIOLOGICS·20190821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173242.

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