510(k) K012869— GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25

Substantially Equivalent

Gimmi GmbH

Clearance details

Applicant: Gimmi GmbH
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2001-08-27
Decision date: 2002-03-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amsterdam, Nh, NL

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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.