GYN-1500 HYSTEROSCOPIC INUFFLATOR— 510(k) K905706

Name: FDA 510(k) clearance K905706
Creator: U.S. Food and Drug Administration
Published: 1991-02-28

Substantially Equivalent

Circon Acmi

FDA 510(k) clearance K905706 for GYN-1500 HYSTEROSCOPIC INUFFLATOR, Substantially Equivalent on 1991-02-28. Applicant: Circon Acmi. Device class: 2.

Clearance details

Applicant: Circon Acmi
Product code: Code HIG
Device class: Class 2
Regulation: 21 CFR 884.1700
Advisory panel: Obstetrics/Gynecology
Date received: 1990-12-24
Decision date: 1991-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, 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.