ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
FDA 510(k) clearance K213633 · decided 2022-04-08
Clearance details
- K-number
- K213633
- Device name
- ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-11-17
- Decision date
- 2022-04-08
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GAG
- Device class
- 2
- Regulation number
- 878.4740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.