DeviceClearance

ETHICON Circular Stapler (CDH21mm) +7 more— 510(k) K260196

Substantially Equivalent

Ethicon Endo-Surgery, LLC

FDA 510(k) clearance K260196 for ETHICON Circular Stapler (CDH21mm) +7 more, Substantially Equivalent on 2026-05-11. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.

Summary

Ethicon Endo-Surgery's record covers eight ETHICON Circular Stapler entries: CDH21mm, CDH25mm, CDH29mm and CDH33mm, plus XL Sealed versions ECS21mm, ECS25mm, ECS29mm and ECS33mm. The product code is GDW, implantable staples.

Class II, 21 CFR 878.4750. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Ethicon filed from Guaynabo, Puerto Rico. Review took 109 calendar days (January 22 to May 11, 2026).

Clearance details

Device name as filed
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)
Applicant
Ethicon Endo-Surgery, LLC
Product code
Product code GDW
Device class
Class 2
Regulation
21 CFR 878.4750
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guaynabo, PR, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GDW

product code GDW
Death
450
Injury
12,684
Malfunction
68,730
Other
6
Total
81,870

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.