Atlas FDA

Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm

FDA 510(k) clearance K202665 · decided 2020-10-15

Clearance details

K-number
K202665
Device name
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
Applicant
Ethicon Endo-Surgery, LLC
Decision
Substantially Equivalent
Date received
2020-09-14
Decision date
2020-10-15
Days to decision
31 days
Clearance type
Special
Product code
GDW
Device class
2
Regulation number
878.4750
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Guaynabo, PR, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.