Suture Welding System and Kit-(J-Tip Design)
FDA 510(k) K002557 · Axya Medical, Inc.
510(k) numberK002557
Submission
- Device name
- Suture Welding System and Kit-(J-Tip Design)
- Applicant
- Axya Medical, Inc.
Beverly, MA, US - Received
- August 17, 2000
- Decision date
- October 6, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | ETHICON, Inc. | 03/27/2026SE |
| K233355 | Cypris eXact Suturing SystemGAW · Traditional | Cypris Medical | 01/12/2024SE |
| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
| K221280 | VessealGAW · Traditional | Lydus Medical , Ltd. | 12/09/2022SE |
| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
More from Aesculap, Inc.
| 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 |
| K063194 | Tufflex Polyester SutureGAT · Special | 12/04/2006SE |
| 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 |
Questions and answers
When was Suture Welding System and Kit-(J-Tip Design) cleared by the FDA?
Suture Welding System and Kit-(J-Tip Design) (K002557) received a 510(k) decision of Substantially Equivalent on October 6, 2000, 50 days after the submission was received.
What is the product code of K002557?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.