Cleared Traditional

CANNULA, SUCTION UTERINE

K900641 · Williams Specialty Products, Inc. · Obstetrics & Gynecology
Mar 1990
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K900641 is an FDA 510(k) clearance for the CANNULA, SUCTION UTERINE, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Williams Specialty Products, Inc. (Encino, US). The FDA issued a Cleared decision on March 30, 1990, 49 days after receiving the submission on February 9, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number K900641 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1990
Decision Date March 30, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHI — System, Abortion, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5070