CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
FDA 510(k) K201313 · Aziyo Biologics, Inc.
510(k) numberK201313
Submission
- Device name
- CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
- Applicant
- Aziyo Biologics, Inc.
Roswell, GA, US - Received
- May 18, 2020
- Decision date
- June 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | Synovis Life Technologies, Inc. | 04/07/2023SE |
| K214070 | OviTex PRS (Long Term Resorbable)FTM · Traditional | Tela Bio | 03/21/2023SE |
| K213163 | VersaWrapFTM · Special | Alafair Biosciences, Inc. | 10/29/2021SE |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special | Synovis Life Technologies. Inc. (A Subsidiary of… | 10/27/2021SE |
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | 10/21/2019SE |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…FTM · Traditional | 11/15/2018SE |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | 10/25/2017SE |
Questions and answers
When was CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) cleared by the FDA?
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (K201313) received a 510(k) decision of Substantially Equivalent on June 15, 2020, 28 days after the submission was received.
What is the product code of K201313?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.