Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed— 510(k) K201280
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K201280 for Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed, Substantially Equivalent on 2020-07-27. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Product 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
- Special
- Location
- Guaynabo, PR, US
Recent devices under product code GDW
view allMore clearances from Ethicon Endo-Surgery, LLC
view all- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
- K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more
- K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C) +6 more
- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 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.