ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)— 510(k) K081146
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K081146 for ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT), Substantially Equivalent on 2008-06-26. 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
- Cincinnati, OH, 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 →
Recalls naming K081146
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081146.
Data sourced from openFDA. This site is unofficial and independent of the FDA.