Cleared Traditional

VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)

K973558 · Ultracell Medical Technologies, Inc. · General Hospital

Nov 1997

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K973558 is an FDA 510(k) clearance for the VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS), a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on November 24, 1997, 66 days after receiving the submission on September 19, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K973558 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 1997
Decision Date	November 24, 1997
Days to Decision	66 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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).