Dual Needle Suture Passer System
FDA 510(k) K082518 · Cayenne Medical, Inc.
510(k) numberK082518
Submission
- Device name
- Dual Needle Suture Passer System
- Applicant
- Cayenne Medical, Inc.
Scottsdale, AZ, US - Received
- September 2, 2008
- Decision date
- January 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K192428 | AFX Femoral Implant with InserterMBI · Special | 10/05/2019SE |
| K180274 | Ventix Link Knotless Anchor with InserterMBI · Traditional | 03/21/2018SE |
| K172186 | BioWick X Implant with DriverMBI · Traditional | 10/16/2017SE |
| K161033 | AFX Femoral Implant With InserterMBI · Special | 08/03/2016SE |
| K151068 | SureLock W Suture AnchorMBI · Traditional | 07/24/2015SE |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…MBI · Traditional | 03/25/2015SE |
| K143392 | Quattro Bolt Tenodesis ScrewMBI · Traditional | 01/23/2015SE |
| K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…MBI · Traditional | 12/30/2013SE |
| K131325 | Quattro GL Suture AnchorMBI · Traditional | 08/16/2013SE |
| K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-PEEK OnlyMBI · Traditional | 10/31/2012SE |
Questions and answers
When was Dual Needle Suture Passer System cleared by the FDA?
Dual Needle Suture Passer System (K082518) received a 510(k) decision of Substantially Equivalent on January 16, 2009, 136 days after the submission was received.
What is the product code of K082518?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.