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

Name: FDA 510(k) clearance K905747
Creator: U.S. Food and Drug Administration
Published: 1991-09-17

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. Device class: 2.

Clearance details

Applicant: Coopervision Surgical
Product code: Code HGI
Device class: Class 2
Regulation: 21 CFR 884.4120
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

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K905747

K-number listed on FDA's recall record

Z-0484-2015 — CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.Class II·Terminated·CooperSurgical, Inc.·20141027

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905747.

Data sourced from openFDA. This site is unofficial and independent of the FDA.