WALLACH LEEP PROCEDURE KIT— 510(k) K935634

Name: FDA 510(k) clearance K935634
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

Wallach Surgical Devices, Inc.

FDA 510(k) clearance K935634 for WALLACH LEEP PROCEDURE KIT, Substantially Equivalent on 1994-07-20. Applicant: Wallach Surgical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Wallach Surgical Devices, Inc.
Product code: Code HGI
Device class: Class 2
Regulation: 21 CFR 884.4120
Advisory panel: Obstetrics/Gynecology
Date received: 1993-11-23
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, 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 →

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