DeviceClearance

ECHELON LINEAR 60 mm Cutter (GLC60) +8 more— 510(k) K223760

Substantially Equivalent

Ethicon Endo-Surgery

FDA 510(k) clearance K223760 for ECHELON LINEAR 60 mm Cutter (GLC60) +8 more, Substantially Equivalent on 2023-03-15. Applicant: Ethicon Endo-Surgery. Device class: 2.

Clearance details

Device name as filed
ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)
Applicant
Ethicon Endo-Surgery
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
Download summary PDFView on FDA.gov ↗

Recent devices under product code GDW

view all

More clearances from Ethicon Endo-Surgery

view all

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 K223760

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223760.

Data sourced from openFDA. This site is unofficial and independent of the FDA.