Cleared Traditional

K915402 - EW-10 AND EW-20
(FDA 510(k) Clearance)

K915402 · Olympus Corp. · General Hospital

Jun 1995

Decision

1297d

Days

Class 2

Risk

K915402 is an FDA 510(k) clearance for the EW-10 AND EW-20, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on June 23, 1995, 1297 days after receiving the submission on December 4, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K915402 FDA.gov
FDA Decision	Cleared SN
Date Received	December 04, 1991
Decision Date	June 23, 1995
Days to Decision	1297 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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).