Cleared Traditional

Nasal Aspirator (NS 13)

K241852 · Avita Corporation · Ear, Nose, Throat
Dec 2024
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K241852 is an FDA 510(k) clearance for the Nasal Aspirator (NS 13), a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 31, 2024, 187 days after receiving the submission on June 27, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K241852 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2024
Decision Date December 31, 2024
Days to Decision 187 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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