510(k) K252906

Device: ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
Applicant: Ethicon Endo-Surgery, LLC
510(k) number: K252906
Product code: OXC
Decision: Substantially Equivalent (SESE)
Decision date: 2026-01-09
Date received: 2025-09-12
Regulation: 878.3300
Classification name: Mesh, Surgical, Absorbable, Staple Line Reinforcement
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Roberta Cabral Franca
Address: 475 Calle C , Pr United States Guaynabo PR US 00696 00696

FDA Registration Numbers

1219930
3003898360
3014479313
3010668881
3012481535
3014272734
1213643
3005636544
3002294946
3003910212
1527736
3027419979
3009380063
9613662
3018094310
3006082230
3011137372
1319639
3021194552
3010041511
3005075853

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OXC

510(k)	Device	Applicant	Decision date
K231603	Standard Staple-Line Reinforcement (SSLR23)	Standard Bariatrics, Inc.	2023-10-06
K221343	ECHELON ENDOPATH Staple Line Reinforcement	Ethicon Endo-Surgery, LLC	2022-09-16
K221487	NEOVEIL Staple Line Reinforcement	Gunze Limited	2022-08-26
K190937	Echelon Endopath Staple Line Reinforcement	Ethicon Endo-Surgery, LLC	2019-10-14
K181940	GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement	W. L. Gore & Associates, Inc.	2018-08-17
K150551	GORE SEAMGUARD Reinforcement	W. L. Gore & Associates, Inc.	2015-03-30
K130997	NEOVEIL	Gunze Limited	2013-11-15
K131658	GORE SEAMGUARD REINFORCEMENT	W. L. Gore & Associates, Inc.	2013-09-06