Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079
FDA 510(k) K051848 · Davol Inc., Sub. C. R. Bard, Inc.
510(k) numberK051848
Submission
- Device name
- Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
Canston, RI, US - Received
- July 7, 2005
- Decision date
- August 11, 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
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| 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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| 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 |
| K050610 | Salute Fixation SystemGDW · Traditional | 05/25/2005SE |
| 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 II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079 cleared by the FDA?
Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079 (K051848) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 35 days after the submission was received.
What is the product code of K051848?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.