510(k) K261021
- Device
- EasyWhip Family
- Applicant
- Winter Innovations, Inc.
- 510(k) number
- K261021
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-01
- Date received
- 2026-03-27
- 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
Applicant Contact#
- Contact
- Lia Winter
- Address
- 2450 Ej Chapman Dr., Suite 114 Knoxville TN US 37996 37996
FDA Registration Numbers#
- 3013767421
- 3010060157
- 2530154
- 3004638532
- 3015183635
- 3012421607
- 3016678045
- 1043534
- 3035366890
- 3007420745
- 3010452421
- 3012470322
- 3006425876
- 1825034
- 9680794
- 9616062
- 3015806723
- 3012818475
- 3021393544
- 3015207155
- 3007663067
- 2183301
- 3004111573
- 3022518322
- 3000215346
- 3005180920
- 3027605742
- 9611459
- 3007109793
- 3011061237
- 1526012
- 2011171
- 3003267729
- 2090040
- 1000307092
- 3009532798
- 3043226252
- 9616088
- 1054811
- 1058584
- 3011137372
- 3013548553
- 3030655570
- 3038503932
- 1066741
- 3014286836
- 3011689956
- 3014615644
- 1017294
- 1043214
- 3007319107
- 3003139373
- 3022472578
- 3009756327
- 3011276344
- 3014004349
- 3003639970
- 1319660
- 3014461810
- 3017210488
- 3003755939
- 3010692967
- 3010146686
- 3014579161
- 1220246
- 3020983460
- 2028632
- 3016904853
- 3017196117
- 3010041511
- 3013176080
- 2032098
- 3006108336
- 3008868758
- 3009513193
- 3015542154
- 3013756169
- 3003604053
- 3029901632
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 |