510(k) K202994
K202994 is an FDA 510(k) premarket notification submitted by Taiwan Surgical Corporation for the device "InnoClip Disposable Clip Applier, InnoClip Clip Applier". The FDA issued a decision of Substantially Equivalent on January 4, 2022. 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
- January 4, 2022
- Date Received
- October 1, 2020
- 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