ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)— 510(k) K083161

Substantially Equivalent

Conmed Linvatec

FDA 510(k) clearance K083161 for ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100), Substantially Equivalent on 2009-03-27. Applicant: Conmed Linvatec.

Clearance details

Applicant: Conmed Linvatec
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2008-10-27
Decision date: 2009-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.