Atlas FDA

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)

FDA 510(k) clearance K260196 · decided 2026-05-11

Clearance details

K-number
K260196
Device name
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
Decision
Substantially Equivalent
Date received
2026-01-22
Decision date
2026-05-11
Days to decision
109 days
Clearance type
Traditional
Product code
GDW
Device class
2
Regulation number
878.4750
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Guaynabo, PR, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.