Cleared Traditional

FirstFit Surgical Kit

K240763 · Freudenberg Medical, LLC · Ear, Nose, Throat

Dec 2024

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K240763 is an FDA 510(k) clearance for the FirstFit Surgical Kit, a Prosthesis, Laryngeal (taub) (Class II — Special Controls, product code EWL), submitted by Freudenberg Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on December 18, 2024, 273 days after receiving the submission on March 20, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3730.

Submission Details

510(k) Number	K240763 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2024
Decision Date	December 18, 2024
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF