510(k) K200874
K200874 is an FDA 510(k) premarket notification submitted by Innovasis, Inc. for the device "TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End". The FDA issued a decision of Substantially Equivalent on June 30, 2020. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Innovasis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2020
- Date Received
- April 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type