POWERTREK INSTRUMENTS— 510(k) K972057

Substantially Equivalent

Medtrek Corp.

FDA 510(k) clearance K972057 for POWERTREK INSTRUMENTS, Substantially Equivalent on 1997-11-05. Applicant: Medtrek Corp..

Clearance details

Applicant: Medtrek Corp.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1997-06-02
Decision date: 1997-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.