ENT IRRIGATING PUMP (70327700)— 510(k) K973286

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K973286 for ENT IRRIGATING PUMP (70327700), Substantially Equivalent on 1997-09-29. Applicant: Gyrus Ent LLC.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-02
Decision date: 1997-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, 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.