CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
FDA 510(k) K182255 · Aziyo Biologics, Inc.
510(k) numberK182255
Submission
- Device name
- CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
- Applicant
- Aziyo Biologics, Inc.
Roswell, GA, US - Received
- August 20, 2018
- Decision date
- November 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | 06/15/2020SE |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | 10/21/2019SE |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | 10/25/2017SE |
Questions and answers
When was CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) cleared by the FDA?
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (K182255) received a 510(k) decision of Substantially Equivalent on November 15, 2018, 87 days after the submission was received.
What is the product code of K182255?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.