Apex Locator, DPEX III— 510(k) K181087

Substantially Equivalent

Guilin Woodpecker Medical Instrument Co., Ltd.

FDA 510(k) clearance K181087 for Apex Locator, DPEX III, Substantially Equivalent on 2018-12-18. Applicant: Guilin Woodpecker Medical Instrument Co., Ltd..

Clearance details

Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Product code
Code LQY
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guilin City, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code LQY

product code LQY
Malfunction
504
Total
504

Source: openFDA MAUDE database, through . 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.