ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)
Ethicon Endo-Surgery, LLC · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Guaynabo
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 475 Calle C
- Statement or summary
- Summary
- Product code
- GDW
- Zip code
- 00969
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision date
- 2025-02-25
- Decision code
- SESE
- Country code
- US
- Advisory committee
- SU
- Contact
- Aysenur Huseyinoglu Erucman
- K number
- K243276
- State
- PR
- Date received
- 2024-10-16
- Review advisory committee
- SU
- Postal code
- 00969
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)
- Harmonized identifiers (openFDA)
- Device name
- Staple, Implantable
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4750
- Device class
- 2
- Registration number
- 3006787036, 3010913847, 3021194552, 3018094310, 3003700453, 3010326740, 3016555232, 3014479313, 3035387162, 1650907, 3010377594, 3015612252, 2029015, 2244478, 3014295858, 3011301103, 3016248634, 3026606306, 1055236, 3013002341, 3011063460, 3021632375, 3004111573, 3009931872, 3011137372, 2953359, 3016668451, 3017820152, 3022626486, 3014932737, 3014635169, 3013665681, 3011052945, 2023739, 3021604067, 3024021261, 3015183635, 3011989923, 9612501, 3010131137 +118 more
- FEI number
- 3006787036, 3010913847, 3021194552, 3018094310, 3003700453, 3010326740, 3016555232, 3014479313, 1000160458, 3035387162, 3002993297, 3010377594, 3015612252, 3014295858, 3011301103, 3016248634, 3026606306, 3013002341, 3011063460, 3021632375, 3004111573, 3009931872, 3016668451, 3017820152, 3022626486, 3014932737, 3014635169, 3013665681, 3011052945, 1000138054, 2023739, 3003076831, 3021604067, 3024021261, 3015183635, 3011989923, 3010131137, 3007137643, 3010684280, 2020394 +118 more