510(k) K230480
K230480 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)". The FDA issued a decision of Substantially Equivalent on April 28, 2023. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Teleflex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2023
- Date Received
- February 22, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type