Cleared Traditional

Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

K230536 · Hunan Vathin Medical Instrument Co., Ltd. · Ear, Nose, Throat

Jun 2023

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K230536 is an FDA 510(k) clearance for the Single-use Flexible Rhinolaryngoscope; Digital Video Monitor, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xiangtan, CN). The FDA issued a Cleared decision on June 14, 2023, 107 days after receiving the submission on February 27, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K230536 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2023
Decision Date	June 14, 2023
Days to Decision	107 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).