510(k) K111763
K111763 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. for the device "PATHASSIST LIGHT FIBER". The FDA issued a decision of Substantially Equivalent on September 15, 2011. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Entellus Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2011
- Date Received
- June 23, 2011
- 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