HS Fiber
FDA 510(k) K202242 · Riverpoint Medical, LLC
510(k) numberK202242
Submission
- Device name
- HS Fiber
- Applicant
- Riverpoint Medical, LLC
Portland, OR, US - Received
- August 10, 2020
- Decision date
- September 10, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K262677 | Iconix Knotless TMBI · Special | 08/27/2026SE |
| K253693 | Strut Suture; No-Tie ButtonMBI · Traditional | 03/11/2026SE |
| K253695 | LigaMendMBI · Traditional | 02/27/2026SE |
| K253024 | ProZip Knotless ImplantGAT · Special | 10/16/2025SE |
| K252201 | HS FiberGAT · Special | 08/13/2025SE |
| K252144 | Iconix Speed Anchor; Iconix Speed HA+ AnchorMBI · Special | 07/30/2025SE |
| K243988 | RootMend MRRMBI · Traditional | 03/20/2025SE |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructMBI · Traditional | 11/26/2024SE |
| K243323 | Iconix Knotless AnchorMBI · Special | 11/19/2024SE |
| K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorMBI · Special | 10/29/2024SE |
Questions and answers
When was HS Fiber cleared by the FDA?
HS Fiber (K202242) received a 510(k) decision of Substantially Equivalent on September 10, 2020, 31 days after the submission was received.
What is the product code of K202242?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.