GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE— 510(k) K971374

Substantially Equivalent

Wilson Greatbatch Technologies, Inc.

FDA 510(k) clearance K971374 for GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE, Substantially Equivalent on 1998-05-13. Applicant: Wilson Greatbatch Technologies, Inc..

Clearance details

Applicant: Wilson Greatbatch Technologies, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1997-04-14
Decision date: 1998-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clarence, NY, 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.