510(k) K254275
- Device
- HyperSuture All Green Extension Line
- Applicant
- Threadstone, LLC
- 510(k) number
- K254275
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-23
- Date received
- 2025-12-30
- 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
- Steven Boudouris
- Address
- 1035 Benfield Blvd. Suite H Millersville MD US 21108 21108
FDA Registration Numbers#
- 3043620689
- 3013767421
- 3015974593
- 3007205024
- 3007109793
- 3010041511
- 3005160949
- 3012103978
- 3006272282
- 3009905888
- 1721676
- 3011989923
- 1221934
- 9610622
- 3004549189
- 3007791573
- 3003267729
- 1043534
- 3014004349
- 3029754081
- 3011683674
- 3013403214
- 2246552
- 3006425876
- 3020983460
- 3014276972
- 2523676
- 3045857302
- 3004192065
- 1221051
- 3010163695
- 3002719998
- 3010692967
- 3016678045
- 2244478
- 3005180920
- 1423537
- 3013668043
- 3017499940
- 3012329552
- 1064584
- 3008142750
- 1000484830
- 3006017180
- 3011276344
- 2320767
- 9612501
- 3005381997
- 3022472578
- 3029901632
- 3044819802
- 3012818475
- 3014479313
- 1526012
- 3004060107
- 9680794
- 2011171
- 3016727307
- 3016904853
- 3018094310
- 3005064037
- 1221601
- 1064017
- 3013700547
- 2650143
- 3010400367
- 3014286836
- 3003639970
- 3016926753
- 3004447686
- 3030655570
- 1000307092
- 3001592626
- 1017294
- 1058584
- 2245304
- 3012502601
- 8044102
- 3008650117
- 3013187142
Source Documents#
Other 510(k) Records For Product Code GAT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026-08-22 |
| K261021 | EasyWhip Family | Winter Innovations, Inc. | 2026-07-01 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026-05-06 |
| 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 |