LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR— 510(k) K905747

Substantially Equivalent

Coopervision Surgical

FDA 510(k) clearance K905747 for LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR, Substantially Equivalent on 1991-09-17. Applicant: Coopervision Surgical.

Clearance details

Applicant: Coopervision Surgical
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1990-12-24
Decision date: 1991-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code HGI

product code HGI

Other: 1
Total: 1

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.