Cleared Traditional

JESBERG ESOPHAGOSCOPE

K892259 · Zinnanti Surgical Instruments, Inc. · Ear, Nose, Throat

Jun 1989

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K892259 is an FDA 510(k) clearance for the JESBERG ESOPHAGOSCOPE, a Esophagoscope (flexible Or Rigid) (Class II — Special Controls, product code EOX), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 16, 1989, 73 days after receiving the submission on April 4, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4710.

Submission Details

510(k) Number	K892259 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 1989
Decision Date	June 16, 1989
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	EOX — Esophagoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4710
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).