510(k) K150259
K150259 is an FDA 510(k) premarket notification submitted by Taiwan Surgical Corporation for the device "CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L". The FDA issued a decision of Substantially Equivalent on November 6, 2015. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Taiwan Surgical Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2015
- Date Received
- February 3, 2015
- Clearance Type
- Traditional
- 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