Biofiber Syture
FDA 510(k) K122487 · Tornier, Inc.
510(k) numberK122487
Submission
- Device name
- Biofiber Syture
- Applicant
- Tornier, Inc.
Bloomington, MN, US - Received
- August 15, 2012
- Decision date
- September 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NWJ – Suture, Recombinant Technology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4494
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Other 510(k)s with product code NWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211307 | GalaSTITCH Absorbable Monofilament SutureNWJ · Special | Tepha, Inc. | 05/27/2021SE |
| K132348 | Tephaflex Braided SutureNWJ · Traditional | Tepha, Inc. | 09/05/2013SE |
| K130422 | Phantom Fiber Biofiber SutureNWJ · Special | Tornier, Inc. | 04/04/2013SE |
| K100876 | Aesculap Monomax Absorbable SutureNWJ · Traditional | Aesculap, Inc. | 07/14/2010SE |
| K082178 | Tephaflex Absorbable SutureNWJ · Traditional | Tepha, Inc. | 10/30/2008SE |
| K081099 | Tephaflex Absorbable SutureNWJ · Traditional | Tepha, Inc. | 07/15/2008SE |
| K072470 | Bioelast 5-0 Suture, Model 500100NWJ · Traditional | Entrigue Surgical, Inc. | 11/16/2007SE |
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Questions and answers
When was Biofiber Syture cleared by the FDA?
Biofiber Syture (K122487) received a 510(k) decision of Substantially Equivalent on September 17, 2012, 33 days after the submission was received.
What is the product code of K122487?
The FDA product code is NWJ – Suture, Recombinant Technology, a Class II (moderate risk) device regulated under 21 CFR 878.4494.