Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
FDA 510(k) K260775 · Teleflex Medical, LLC
510(k) numberK260775
Submission
- Device name
- Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
- Applicant
- Teleflex Medical, LLC
Morrisville, NC, US - Received
- March 10, 2026
- Decision date
- May 6, 2026
- 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 |
| 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 |
| K241376 | HyperSuture All Blue Extension LineGAT · Traditional | Threadstone, LLC | 08/09/2024SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | 07/09/2026SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | 07/03/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | 04/29/2025SE |
| K243553 | QuikClot Control+ Hemostatic DevicePOD · Traditional | 03/18/2025SE |
| K241784 | Arrow® Nitinol WireDQX · Traditional | 09/18/2024SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | 03/22/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | 01/12/2024SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | 08/30/2023SE |
| K231924 | EZ-IO Intraosseous Vascular Access SystemFMI · Special | 07/25/2023SE |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)FZP · Special | 04/28/2023SE |
Questions and answers
When was Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape cleared by the FDA?
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape (K260775) received a 510(k) decision of Substantially Equivalent on May 6, 2026, 57 days after the submission was received.
What is the product code of K260775?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.