510(k) K131177
K131177 is an FDA 510(k) premarket notification submitted by Hedgepath, LLC for the device "SINUFLUSH LAVAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 2013. The device falls under product code KAR (Irrigator, Sinus), a Class I device regulated under 21 CFR 874.4420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2013
- Date Received
- April 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Irrigator, Sinus
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type