Cleared Traditional

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY

K915816 · Gi Supply · Ear, Nose, Throat

Mar 1992

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K915816 is an FDA 510(k) clearance for the BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on March 27, 1992, 88 days after receiving the submission on December 30, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K915816 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 1991
Decision Date	March 27, 1992
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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).