AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR— 510(k) K971492

Name: FDA 510(k) clearance K971492
Creator: U.S. Food and Drug Administration
Published: 1997-09-05

Substantially Equivalent

Bei Medical Systems Co., Inc.

FDA 510(k) clearance K971492 for AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR, Substantially Equivalent on 1997-09-05. Applicant: Bei Medical Systems Co., Inc.. Device class: 2.

Clearance details

Applicant: Bei Medical Systems Co., Inc.
Product code: Code HIG
Device class: Class 2
Regulation: 21 CFR 884.1700
Advisory panel: Obstetrics/Gynecology
Date received: 1997-04-24
Decision date: 1997-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.