510(k) K113697
K113697 is an FDA 510(k) premarket notification submitted by Invuity, Inc. for the device "EIGR SURGICAL ILLUMINATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 10, 2012. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Invuity, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2012
- Date Received
- December 16, 2011
- Clearance Type
- Special
- 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