RiverLon (Nylon) Suture
FDA 510(k) K152795 · Riverpoint Medical
510(k) numberK152795
Submission
- Device name
- RiverLon (Nylon) Suture
- Applicant
- Riverpoint Medical
Portland, OR, US - Received
- September 28, 2015
- Decision date
- October 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAR – Suture, Nonabsorbable, Synthetic, Polyamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5020
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261484 | Tissue Approximation SystemGAR · Special | Tas Medical, Inc. | 06/03/2026SE |
| K220980 | Tissue Approximation System (TAS)GAR · Traditional | Tas Medical, Inc. | 07/05/2023SE |
| K212888 | Golnit Nylon Monofilament SutureGAR · Abbreviated | Antarma, LLC Dba Golnit Sutures | 03/31/2022SE |
| K212603 | Non Absorbable Surgical Nylon SutureGAR · Traditional | Shandong Haidike Medical Product Co., Ltd. | 12/22/2021SE |
| K192420 | Crownjun Nylon SutureGAR · Traditional | Kono Seisakusho Co., Ltd. | 05/29/2020SE |
| K161633 | Rexlon, RexsilGAR · Traditional | Sm Eng Co., Ltd. | 03/02/2017SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 02/17/2016SE |
| K123034 | Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional | Unilene Sac | 05/28/2013SE |
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | Nashville Surgical Instruments | 07/15/2008SE |
| K060471 | FSSB Nylon Surgical SuturesGAR · Abbreviated | Fssb Chirurgische Nadeln GmbH | 07/26/2006SE |
More from Fssb Chirurgische Nadeln GmbH
| 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 RiverLon (Nylon) Suture cleared by the FDA?
RiverLon (Nylon) Suture (K152795) received a 510(k) decision of Substantially Equivalent on October 28, 2015, 30 days after the submission was received.
What is the product code of K152795?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.