510(k) K130503

PATHASSIST LED LIGHT FIBER by Entellus Medical, Inc. — Product Code LRC

K130503 is an FDA 510(k) premarket notification submitted by Entellus Medical, Inc. for the device "PATHASSIST LED LIGHT FIBER". The FDA issued a decision of Substantially Equivalent on June 11, 2013. 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
June 11, 2013
Date Received
February 27, 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