Cleared Traditional

HOBBS MISTIFIER SPRAY CATHETER

K030765 · Hobbs Medical, Inc. · Gastroenterology & Urology

Jun 2003

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K030765 is an FDA 510(k) clearance for the HOBBS MISTIFIER SPRAY CATHETER, a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX), submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on June 9, 2003, 90 days after receiving the submission on March 11, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K030765 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2003
Decision Date	June 09, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	OCX — Endoscopic Irrigation/suction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.