510(k) K140992

ARTHROCARE NASASTENT CMC NASAL DRESSING by ArthroCare Corporation — Product Code LYA

K140992 is an FDA 510(k) premarket notification submitted by ArthroCare Corporation for the device "ARTHROCARE NASASTENT CMC NASAL DRESSING". The FDA issued a decision of Substantially Equivalent on June 16, 2014. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. ArthroCare Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2014
Date Received
April 17, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type