ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler— 510(k) K213633
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K213633 for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler, Substantially Equivalent on 2022-04-08. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guaynabo, PR, US
Recent devices under product code GAG
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- K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more
More clearances from Ethicon Endo-Surgery, LLC
view allAdverse events under product code GAG
product code GAG- Death
- 23
- Injury
- 394
- Malfunction
- 2,304
- Other
- 6
- Total
- 2,727
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.