510(k) K090070
K090070 is an FDA 510(k) premarket notification submitted by Invuity, Inc. for the device "INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on April 22, 2009. 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
- April 22, 2009
- Date Received
- January 12, 2009
- 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