510(k) K241629

Device: 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 Stapl
Applicant: Ethicon Endo-Surgery, LLC
510(k) number: K241629
Product code: GAG
Decision: Substantially Equivalent (SESE)
Decision date: 2024-07-03
Date received: 2024-06-06
Regulation: 878.4740
Classification name: Stapler, Surgical
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Jisha Mlynarczyk
Address: 475 Calle C Guaynabo PR 00969 00969

FDA Registration Numbers

1018470
9681572
3015173212
3012050423
3015612252
3024021261
3015185328
3004450679
1721686
1219930
3017210488
3013188547
3014479313
1058584
3008388437
3030733800
3010373263
3007205024
2244478
3015183635
3007084728
3013388519
2029015
3009931872
3013942591
3004638532
3012998149
3009941480
3015140199
1422634
9611283
1417592
3011989923
3004111573
3010377594
9710649
3007222388
9680518
1222928
3014264910
3009848807
1527736
3017181414
3021632375
3006210673
3021604067
3009380063
3016096100
3017196117
2032112
3018094310
2011171
3010131137
3010326740
3022626486
3018126215
3005273623
3032391
3011529314
3012421607
3005012805
3010432890
3001675293
1061124
2647580
2955842
3012428834
3014461810
3014279513
3018052045
1928237
3001620590
3010611926
3005440795
1650907
3005075853

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code GAG

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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
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	EEACircular 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
K213633	ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler	Ethicon Endo-Surgery, LLC	2022-04-08
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