Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green— 510(k) K200420
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K200420 for Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green, Substantially Equivalent on 2020-06-29. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- 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
Recent devices under product code GDW
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view all- K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
- K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C) +6 more
- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more
- K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) +1 more
- K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) +4 more
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.