Cleared Traditional

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR (K971492) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971492 · Bei Medical Systems Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
134d
Days
Class 2
Risk

K971492 is an FDA 510(k) clearance for the AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Bei Medical Systems Co., Inc. (Hackensack, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bei Medical Systems Co., Inc. devices

Submission Details

510(k) Number K971492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1997
Decision Date September 05, 1997
Days to Decision 134 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 160d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 55
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K971492.
Asurys Fluid Management System
K251273 · Boston Scientific Corporation · Mar 2026
Fluent Pro Fluid Management System (FLT-200)
K240886 · Hologic, Inc. · Jul 2024
X-FLO Fluid Management System
K210628 · Thermedx, LLC · Nov 2021
Endomat Select, IBS Shaver Software, License
K201355 · Karl Storz SE & CO. KG · Jul 2020
Endomat Select
K180735 · Karl Storz SE & CO. KG · Oct 2018
Fluent Fluid Management System
K180825 · Hologic, Inc. · Aug 2018