510(k) K133016
K133016 is an FDA 510(k) premarket notification submitted by Sinusys Corporation for the device "VENT-OS SINUS DILATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 2013. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Sinusys Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2013
- Date Received
- September 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ent Manual Surgical
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type