RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT— 510(k) K112435

Substantially Equivalent

Rhythmlink International, LLC

FDA 510(k) clearance K112435 for RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT, Substantially Equivalent on 2011-09-22. Applicant: Rhythmlink International, LLC.

Clearance details

Applicant: Rhythmlink International, LLC
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2011-08-24
Decision date: 2011-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.