THE DEXTRA PRECISION POWER UNIT— 510(k) K853778

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K853778 for THE DEXTRA PRECISION POWER UNIT, Substantially Equivalent on 1985-11-13. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code GEY
Advisory panel: General, Plastic Surgery
Date received: 1985-09-09
Decision date: 1985-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.