PROMEX ENT TISSUE REMOVAL SYSTEM— 510(k) K972865

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K972865 for PROMEX ENT TISSUE REMOVAL SYSTEM, Substantially Equivalent on 1997-09-29. Applicant: Promex, Inc..

Clearance details

Applicant: Promex, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1997-08-04
Decision date: 1997-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.