Cleared Traditional

Single-Use Flexible Rhinolaryngoscope

K221581 · Hunan Vathin Medical Instrument Co., Ltd. · Ear, Nose, Throat

Nov 2022

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K221581 is an FDA 510(k) clearance for the Single-Use Flexible Rhinolaryngoscope, 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 November 18, 2022, 170 days after receiving the submission on June 1, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K221581 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2022
Decision Date	November 18, 2022
Days to Decision	170 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).