510(k) K202665
- Device
- Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads,
- Applicant
- Ethicon Endo-Surgery, LLC
- 510(k) number
- K202665
- Product code
- GDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-15
- Date received
- 2020-09-14
- Regulation
- 878.4750
- Classification name
- Staple, Implantable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nathan Anderson
- Address
- 475 Calle C Guaynabo PR US 00969 00969
FDA Registration Numbers#
- 3010131137
- 3014279513
- 3016248634
- 3013188547
- 2024311
- 3003700453
- 2022435
- 3010377594
- 3009848807
- 1213643
- 2183449
- 3011137372
- 3016678045
- 3009931872
- 1647149
- 3012050423
- 3012806810
- 3007222388
- 1222928
- 3014461810
- 3014295858
- 1037007
- 3016096100
- 3007093114
- 3021632375
- 2011171
- 3012428834
- 3007544634
- 3003790304
- 9681572
- 2020394
- 3011052945
- 3005075853
- 3030733800
- 1220477
- 3005636544
- 3017210488
- 3007007790
- 3017196117
- 3014479313
- 3009941480
- 1649518
- 3003800159
- 3011989923
- 1423662
- 2032112
- 3010326740
- 1018233
- 3021194552
- 3010432890
- 1064858
- 1450662
- 3010041511
- 1928237
- 3007111496
- 3011050570
- 3007137643
- 1721686
- 3007205024
- 1055236
- 3009380063
- 3006787036
- 3015183635
- 3015336263
- 2029015
- 3008388437
- 3014932737
- 1650907
- 3015185328
- 3018126215
- 3008383115
- 3014264910
- 3017636737
- 3018052045
- 3010913847
- 2648623
- 3015453963
- 1527736
- 1216677
- 2647580
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#
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FDA Review#
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