DeviceClearance

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.. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milford, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HGI

product code HGI
Other
1
Total
1

Source: openFDA MAUDE database, through . 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 K963653

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963653.

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