Cleared Traditional

Rhinolaryngoscope system

K232435 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Ear, Nose, Throat

Apr 2024

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K232435 is an FDA 510(k) clearance for the Rhinolaryngoscope system, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 26, 2024, 256 days after receiving the submission on August 14, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K232435 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2023
Decision Date	April 26, 2024
Days to Decision	256 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).