Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
FDA 510(k) K161221 · Cook Biotech Incorporated
510(k) numberK161221
Submission
- Device name
- Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
- Applicant
- Cook Biotech Incorporated
West Lafayette, IN, US - Received
- April 29, 2016
- Decision date
- May 26, 2016
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | 05/24/2024SE |
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| 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 |
| K170016 | Biodesign Fistula PlugFTM · Traditional | 06/21/2017SE |
| 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 |
Questions and answers
When was Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug cleared by the FDA?
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221) received a 510(k) decision of Substantially Equivalent on May 26, 2016, 27 days after the submission was received.
What is the product code of K161221?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.