ACCESSORIES(PROBES, SUCTION TUBES, ETC.)— 510(k) K812198

Substantially Equivalent

Reznik Instruments

FDA 510(k) clearance K812198 for ACCESSORIES(PROBES, SUCTION TUBES, ETC.), Substantially Equivalent on 1981-09-11. Applicant: Reznik Instruments.

Clearance details

Applicant: Reznik Instruments
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1981-08-04
Decision date: 1981-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.