Cleared Traditional

K902724 - ADVANCE DISPOSABLE STOPCOCK (FDA 510(k) Clearance)

K902724 · Advance Medical Designs, Inc. · General Hospital
Dec 1990
Decision
167d
Days
Class 2
Risk

K902724 is an FDA 510(k) clearance for the ADVANCE DISPOSABLE STOPCOCK. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on December 5, 1990, 167 days after receiving the submission on June 21, 1990.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K902724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date December 05, 1990
Days to Decision 167 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5440