OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES— 510(k) K944704

Substantially Equivalent

Xintec Corporation

FDA 510(k) clearance K944704 for OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES, Substantially Equivalent on 1995-01-06. Applicant: Xintec Corporation.

Clearance details

Applicant: Xintec Corporation
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1994-09-23
Decision date: 1995-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.