K260196
- 510(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 PR · US
- Product code
- GDW — Staple, Implantable
- Decision date
- 2026-05-11
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260196.pdf
Official FDA record: K260196
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.