Cleared Traditional

VCI INSUFLATOR FILTER W/ TUBING

K930192 · Vital Concepts, Inc. · Obstetrics & Gynecology

Mar 1994

Decision

412d

Days

Class 2

Risk

About This 510(k) Submission

K930192 is an FDA 510(k) clearance for the VCI INSUFLATOR FILTER W/ TUBING, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Vital Concepts, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 2, 1994, 412 days after receiving the submission on January 14, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.

Submission Details

510(k) Number	K930192 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 1993
Decision Date	March 02, 1994
Days to Decision	412 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement