510(k) K051848
- Device
- SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
- Applicant
- DAVOL INC., SUB. C.R. BARD, INC.
- 510(k) number
- K051848
- Product code
- GDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-11
- Date received
- 2005-07-07
- Regulation
- 878.4750
- Classification name
- Staple, Implantable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUCINDA L FOX
- Address
- 100 Sockanossett Crossroad Canston RI US 02920 02920
FDA Registration Numbers#
- 3024021261
- 3012050423
- 2024311
- 3003898360
- 2029275
- 3016668451
- 2183449
- 3014295858
- 2244478
- 1216677
- 1423662
- 3012998149
- 3005636544
- 3011052945
- 3008383115
- 3013002341
- 2134494
- 3016248634
- 2648623
- 3011050570
- 3021604067
- 3016096100
- 3017196117
- 3007111496
- 2032112
- 3018094310
- 2011171
- 3010326740
- 2183469
- 1319639
- 1018233
- 3003800159
- 1054241
- 3001675293
- 2647580
- 2955842
- 3012428834
- 1928237
- 3018052045
- 1018470
- 3017636737
- 1064858
- 3015185328
- 1721686
- 1219930
- 9611665
- 3013188547
- 3014479313
- 3008388437
- 1220477
- 3007084728
- 3014932737
- 3015183635
- 1287329
- 2029015
- 3003790304
- 3017102971
- 1037007
- 1055236
- 2020394
- 3013283620
- 3004111573
- 3010377594
- 9616517
- 3003700453
- 3003639920
- 1527736
- 3007093114
- 2953359
- 3009380063
- 3015453963
- 1643817
- 1649518
- 3018126215
- 3014309390
- 1650907
- 3012806810
- 3015612252
- 3016678045
- 1935627
Source Documents#
Other 510(k) Records For Product Code GDW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260196 | ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) | Ethicon Endo-Surgery, LLC | 2026-05-11 |
| K253657 | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads | Covidien (Part of Medtronic) | 2026-04-10 |
| K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) | Ethicon Endo-Surgery, LLC | 2025-12-17 |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | 2025-05-14 |
| K243276 | ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) | Ethicon Endo-Surgery, LLC | 2025-02-25 |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC | 2024-10-28 |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | Fengh Medical Co., Ltd. | 2024-10-04 |
| K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | 2023-05-08 |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2023-04-21 |
| K223760 | ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) | Ethicon Endo-Surgery | 2023-03-15 |
| K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | 2023-01-19 |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | Covidien | 2022-11-30 |
| K222641 | Signia™ Small Diameter Reloads Including Regular (Round) Tip Version | Covidien | 2022-11-29 |
| K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | Covidien | 2022-09-30 |
| K221013 | GIA Auto Suture Stapler with DST Series Technology | Covidien | 2022-05-05 |
Legacy Summary#
summary
FDA Review#
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