510(k) K241852

Nasal Aspirator (NS 13) by Avita Corporation — Product Code BTA

K241852 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "Nasal Aspirator (NS 13)". The FDA issued a decision of Substantially Equivalent on December 31, 2024. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Avita Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2024
Date Received
June 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type