MyEllevate
FDA 510(k) K230510 · Cynosure, LLC
510(k) numberK230510
Submission
- Device name
- MyEllevate
- Applicant
- Cynosure, LLC
Wesford, MA, US - Received
- February 24, 2023
- Decision date
- July 6, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261570 | Picosure WorkstationGEX · Special | 06/17/2026SE |
| K240396 | Elite iQ PRO (M122K1)GEX · Special | 03/08/2024SE |
| K223292 | TempSure SystemGEI · Special | 11/23/2022SE |
| K212891 | TempSure SystemGEI · Traditional | 03/18/2022SE |
| K210226 | PicoSure WorkstationGEX · Traditional | 03/30/2021SE |
| K200241 | TempSure SystemPBX · Traditional | 03/25/2020SE |
| K193426 | Elite iQGEX · Traditional | 03/09/2020SE |
| K190678 | TempSureGEI · Traditional | 07/24/2019SE |
| K182741 | SculpSurePKT · Traditional | 01/03/2019SE |
| K182365 | TempSure SystemGEI · Traditional | 10/24/2018SE |
Questions and answers
When was MyEllevate cleared by the FDA?
MyEllevate (K230510) received a 510(k) decision of Substantially Equivalent on July 6, 2023, 132 days after the submission was received.
What is the product code of K230510?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.