GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE— 510(k) K933173

Substantially Equivalent

Greenwald Surgical Co., Inc.

FDA 510(k) clearance K933173 for GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE, Substantially Equivalent on 1994-04-01. Applicant: Greenwald Surgical Co., Inc..

Clearance details

Applicant: Greenwald Surgical Co., Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1993-06-29
Decision date: 1994-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Station, IN, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.