Tufflex Polyester Suture
FDA 510(k) K063194 · Axya Medical, Inc.
510(k) numberK063194
Submission
- Device name
- Tufflex Polyester Suture
- Applicant
- Axya Medical, Inc.
Beverly, MA, US - Received
- October 20, 2006
- Decision date
- December 4, 2006
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K070773 | Axya, Model 3000 Axyzloop Titanium Bone AnchorMBI · Traditional | 10/11/2007SE |
| K070253 | Axya Suture Welding System and KitGAT · Traditional | 07/11/2007SE |
| K060165 | Axyaflex Polyester SutureGAT · Traditional | 09/01/2006SE |
| K060970 | Axyaloop Nonabsorbable Bone AnchorJDR · Traditional | 07/05/2006SE |
| K052491 | Axya Model 6500 Axyaloop Self-Tapping Bone AnchorMBI · Special | 10/07/2005SE |
| K051983 | Model 3000 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 08/05/2005SE |
| K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 06/09/2005SE |
| K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorMAI · Traditional | 10/05/2004SE |
| K022207 | Axya Model 3000 Axyaloop Titanium Bone Anchor SystemMBI · Traditional | 10/04/2002SE |
| K021929 | Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemLFL · Traditional | 09/10/2002SE |
Questions and answers
When was Tufflex Polyester Suture cleared by the FDA?
Tufflex Polyester Suture (K063194) received a 510(k) decision of Substantially Equivalent on December 4, 2006, 45 days after the submission was received.
What is the product code of K063194?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.