510(k) K230510
- Device
- MyEllevate
- Applicant
- Cynosure, LLC
- 510(k) number
- K230510
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-06
- Date received
- 2023-02-24
- Regulation
- 878.5000
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Cynthia Aguirre
- Address
- 5 Carlisle Rd. Wesford MA US 01886 01886
FDA Registration Numbers
- 1450662
- 3005180920
- 3006498370
- 3021226419
- 3010692967
- 2650143
- 1061124
- 3013176080
- 3002807315
- 3011276344
- 3011689956
- 3007791573
- 3021008900
- 1043534
- 3001592626
- 3014592276
- 3010060157
- 3016727307
- 3027454646
- 2648650
- 3015453963
- 3014276972
- 8044102
- 3006108336
- 2320767
- 3013756169
- 2032098
- 1018470
- 3009513193
- 3007791599
- 1066741
- 3006630150
- 3007420745
- 3015806723
- 3002579136
- 3025603301
- 3012818475
- 2031093
- 3010163695
- 1643264
- 2028632
- 3007205024
- 2246552
- 3010131137
- 1062741
- 1319660
- 1423537
- 1721676
- 1718850
- 3007593722
- 3006562124
- 3006425876
- 3010162973
- 3027339877
- 3013298431
- 3017210488
- 3017636737
- 1045254
- 1320468
- 3017196117
- 3010864832
- 3043620689
- 3013767421
- 3009756327
- 3010860245
- 3013302242
- 2521877
- 3009423112
- 3013548553
- 3032543753
- 3003139373
- 3014262693
- 9611459
- 3014615644
- 3010331645
- 3008483449
- 3030655570
- 3008110533
- 3015330532
Source Documents
Other 510(k) Records For Product Code GAT
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape | Teleflex Medical, LLC | 2026-05-06 |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025-10-16 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 |
| K252201 | HS Fiber | Riverpoint Medical | 2025-08-13 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 |
| K231163 | HS Fiber Sutures | Riverpoint Medical | 2024-01-05 |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023-08-10 |
| K223122 | MENIX®; MENIX® DUO | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 |