Biodesign Fistula Plug
FDA 510(k) K170016 · Cook Biotech Incorporated
510(k) numberK170016
Submission
- Device name
- Biodesign Fistula Plug
- Applicant
- Cook Biotech Incorporated
West Lafayette, IN, US - Received
- January 3, 2017
- Decision date
- June 21, 2017
- 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 |
|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | 05/24/2024SE |
| K201000 | Biodesign Staple Line ReinforcementFTM · Traditional | 07/13/2020SE |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…OXN · Traditional | 12/27/2019SE |
| K171817 | Biodesign Diaphragmatic Hernia GraftFTM · Traditional | 03/13/2018SE |
| K162934 | Biodesign Parastomal Hernia Repair GraftFTM · Traditional | 07/10/2017SE |
| K170945 | Biodesign Staple Line ReinforcementOXE · Special | 04/28/2017SE |
| K161762 | DynaMatrix/Dynamatrix PlusNPL · Special | 01/13/2017SE |
| K162741 | AxoGuard Nerve ConnectorJXI · Special | 10/31/2016SE |
| K160136 | Flowable Wound MatrixKGN · Traditional | 09/28/2016SE |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugFTM · Special | 05/26/2016SE |
Questions and answers
When was Biodesign Fistula Plug cleared by the FDA?
Biodesign Fistula Plug (K170016) received a 510(k) decision of Substantially Equivalent on June 21, 2017, 169 days after the submission was received.
What is the product code of K170016?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.