WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM— 510(k) K963653

Substantially Equivalent

Wallach Surgical Devices, Inc.

FDA 510(k) clearance K963653 for WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM, Substantially Equivalent on 1997-06-11. Applicant: Wallach Surgical Devices, Inc..

Clearance details

Applicant: Wallach Surgical Devices, Inc.
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1996-09-12
Decision date: 1997-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, 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.