510(k) K213633
- Device
- ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
- Applicant
- Ethicon Endo-Surgery, LLC
- 510(k) number
- K213633
- Product code
- GAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-08
- Date received
- 2021-11-17
- Regulation
- 878.4740
- Classification name
- Stapler, Surgical
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- 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#
- 1058584
- 3001620590
- 3021632375
- 3006210673
- 9680518
- 3013188547
- 3005440795
- 3021604067
- 3015140199
- 2647580
- 3011989923
- 1222928
- 2011171
- 1061124
- 3010326740
- 9681572
- 3016096100
- 1417592
- 1928237
- 3032391
- 3009848807
- 3022626486
- 1527736
- 3010373263
- 2955842
- 3017181414
- 3010432890
- 3010377594
- 9611283
- 1018470
- 3010131137
- 3001675293
- 3012428834
- 3015612252
- 3015173212
- 3014279513
- 3004111573
- 3012421607
- 2032112
- 3005075853
- 1650907
- 3018094310
- 2244478
- 3007084728
- 1219930
- 3017196117
- 3008388437
- 3012998149
- 3007205024
- 3013942591
- 3014479313
- 3005273623
- 3024021261
- 1422634
- 2029015
- 9710649
- 3013388519
- 3010611926
- 3014264910
- 3018052045
- 3004450679
- 3014461810
- 3015185328
- 3009931872
- 3011529314
- 3009380063
- 3030733800
- 3007222388
- 3012050423
- 3005012805
- 3004638532
- 3015183635
- 3018126215
- 1721686
- 3009941480
- 3017210488
Source Documents#
Other 510(k) Records For Product Code GAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025-07-11 |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025-03-10 |
| K240881 | Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) | 2024-11-01 |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | Ethicon Endo-Surgery, LLC | 2024-07-03 |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. | 2024-05-07 |
| K231934 | GIA™ Stapler with Tri-Staple™ Technology | Covidien | 2023-10-27 |
| K231491 | TA™ Stapler and Loading Unit with DST Series™ Technology | Covidien | 2023-08-16 |
| K232126 | EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil | Covidien | 2023-08-16 |
| K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) | Covidien | 2023-02-22 |
| K970079 | PROXIMATE DISPOSABLE SKIN STAPLER | Ethicon Endo-Surgery, Inc. | 1997-03-11 |
| K962258 | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP | Ethicon Endo-Surgery, Inc. | 1996-09-11 |
| K934188 | DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART | Deroyal Industries, Inc. | 1994-03-28 |
| K934105 | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES | Surgical Innovations Corp. | 1994-03-28 |
| K932476 | PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER | Ethicon Endo-Surgery, Inc. | 1993-12-01 |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | Richard-Allan Medical | 1993-11-19 |
Legacy Summary#
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FDA Review#
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