510(k) K201882
K201882 is an FDA 510(k) premarket notification submitted by Lexington Medical, Inc. for the device "AEON Endoscopic Stapler". The FDA issued a decision of Substantially Equivalent on October 9, 2020. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Lexington Medical, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2020
- Date Received
- July 8, 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