GalaSTITCH Absorbable Monofilament Suture
FDA 510(k) K211307 · Tepha, Inc.
510(k) numberK211307
Submission
- Device name
- GalaSTITCH Absorbable Monofilament Suture
- Applicant
- Tepha, Inc.
Lexington, MA, US - Received
- April 29, 2021
- Decision date
- May 27, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K132348 | Tephaflex Braided SutureNWJ · Traditional | Tepha, Inc. | 09/05/2013SE |
| K130422 | Phantom Fiber Biofiber SutureNWJ · Special | Tornier, Inc. | 04/04/2013SE |
| K122487 | Biofiber SytureNWJ · Traditional | Tornier, Inc. | 09/17/2012SE |
| 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 |
More from Entrigue Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233999 | GalaFLEX LITE ScaffoldOOD · Traditional | 04/09/2024SE |
| K202425 | SurgiLattice scaffoldOOD · Traditional | 08/19/2021SE |
| K162922 | GalaFORM 3DOOD · Traditional | 02/23/2017SE |
| K161092 | GalaSHAPE 3DOOD · Traditional | 08/23/2016SE |
| K140533 | Galaflex MeshOOD · Traditional | 05/21/2014SE |
| K132348 | Tephaflex Braided SutureNWJ · Traditional | 09/05/2013SE |
| K130326 | Tephaflex Meltblown ConstructOOD · Traditional | 05/07/2013SE |
| K113723 | Tephaflex MeshOOD · Traditional | 02/15/2012SE |
| K113721 | Tephaflex Light MeshOOD · Traditional | 02/15/2012SE |
| K111946 | Tephaflex MeshOOD · Traditional | 09/26/2011SE |
Questions and answers
When was GalaSTITCH Absorbable Monofilament Suture cleared by the FDA?
GalaSTITCH Absorbable Monofilament Suture (K211307) received a 510(k) decision of Substantially Equivalent on May 27, 2021, 28 days after the submission was received.
What is the product code of K211307?
The FDA product code is NWJ – Suture, Recombinant Technology, a Class II (moderate risk) device regulated under 21 CFR 878.4494.