Salute Fixation System
FDA 510(k) K050610 · Davol Inc., Sub. C. R. Bard, Inc.
510(k) numberK050610
Submission
- Device name
- Salute Fixation System
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
Canston, RI, US - Received
- March 10, 2005
- Decision date
- May 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
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| K092032 | Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160FTL · Traditional | 12/08/2009SE |
| K081010 | Bard 3DMAX MeshFTL · Traditional | 10/07/2008SE |
| K061754 | Bard Composite L/P MeshFTL · Traditional | 10/23/2006SE |
| K061314 | Bard Extra Large Composix Kugel Hernia PatchFTL · Traditional | 06/02/2006SE |
| K051848 | Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079GDW · Traditional | 08/11/2005SE |
| K011069 | Aquasens Fluid Monitoring SystemHIG · Traditional | 08/16/2001SE |
| K003674 | Nezhat-Dorsey Reusable Electrosurgical Attachments: J-Hook Tip, L-Hook Tip, Corbitt…GEI · Traditional | 12/08/2000SE |
| K991799 | Davol Hysteroscopy Pouch Drape and Tubing Set, Model OoxxxxoHIG · Traditional | 09/13/1999SE |
| K991637 | Bard Sperma-Tex Preshaped Mesh (2.4X5.6), Model 0114700FTL · Traditional | 06/22/1999SE |
Questions and answers
When was Salute Fixation System cleared by the FDA?
Salute Fixation System (K050610) received a 510(k) decision of Substantially Equivalent on May 25, 2005, 76 days after the submission was received.
What is the product code of K050610?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.