MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH— 510(k) K972426

Substantially Equivalent

Imagyn Medical, Inc.

FDA 510(k) clearance K972426 for MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH, Substantially Equivalent on 1997-09-23. Applicant: Imagyn Medical, Inc..

Clearance details

Applicant: Imagyn Medical, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1997-06-27
Decision date: 1997-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

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Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.