KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES— 510(k) K944795

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K944795 for KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES, Substantially Equivalent on 1994-12-21. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-28
Decision date: 1994-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, 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.