Cleared Traditional

INSUFFLATOR TUBING KIT

K922197 · O.R. Concepts, Inc. · Obstetrics & Gynecology
Sep 1993
Decision
501d
Days
Class 2
Risk

About This 510(k) Submission

K922197 is an FDA 510(k) clearance for the INSUFFLATOR TUBING KIT, a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on September 24, 1993, 501 days after receiving the submission on May 11, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K922197 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1992
Decision Date September 24, 1993
Days to Decision 501 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HIG — Insufflator, Hysteroscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1700

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