Cleared Traditional

HOBBS MEDICAL CLEANING BRUSH

K933354 · Hobbs Medical, Inc. · General Hospital

Oct 1993

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K933354 is an FDA 510(k) clearance for the HOBBS MEDICAL CLEANING BRUSH, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Hobbs Medical, Inc. (Palmer, US). The FDA issued a Cleared decision on October 28, 1993, 111 days after receiving the submission on July 9, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K933354 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 1993
Decision Date	October 28, 1993
Days to Decision	111 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).