POREX OTOLOGY INSTRUMENTS— 510(k) K873044

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K873044 for POREX OTOLOGY INSTRUMENTS, Substantially Equivalent on 1987-09-04. Applicant: Porex Medical.

Clearance details

Applicant: Porex Medical
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 1987-08-04
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

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.