510(k) K200420
K200420 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green". The FDA issued a decision of Substantially Equivalent on June 29, 2020. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ethicon Endo-Surgery, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2020
- Date Received
- February 20, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type