510(k) K242679
K242679 is an FDA 510(k) premarket notification submitted by Fengh Medical Co., Ltd. for the device "Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)". The FDA issued a decision of Substantially Equivalent on October 4, 2024. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Fengh Medical Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2024
- Date Received
- September 6, 2024
- Clearance Type
- Special
- 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