Cleared Traditional

PatCom Distal Chip Endoscope

K222587 · H&A Mui Enterprises, Inc. · Ear, Nose, Throat

Jul 2023

Decision

336d

Days

Class 2

Risk

About This 510(k) Submission

K222587 is an FDA 510(k) clearance for the PatCom Distal Chip Endoscope, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by H&A Mui Enterprises, Inc. (Mississauga, CA). The FDA issued a Cleared decision on July 28, 2023, 336 days after receiving the submission on August 26, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K222587 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2022
Decision Date	July 28, 2023
Days to Decision	336 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).