Cleared Traditional

ACCESS EXPANSION SYSTEM

K951894 · Micro-Medical Devices, Inc. · Gastroenterology & Urology

Jun 1995

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K951894 is an FDA 510(k) clearance for the ACCESS EXPANSION SYSTEM, a Pneumoperitoneum Needle (Class II — Special Controls, product code FHO), submitted by Micro-Medical Devices, Inc. (Castle Pines Village, US). The FDA issued a Cleared decision on June 15, 1995, 52 days after receiving the submission on April 24, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K951894 FDA.gov
FDA Decision	Cleared SESK
Date Received	April 24, 1995
Decision Date	June 15, 1995
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	FHO — Pneumoperitoneum Needle
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	For Establishment Of A Pneumoperitoneum In Abdomen.