GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03— 510(k) K013731

Substantially Equivalent

Gimmi GmbH

FDA 510(k) clearance K013731 for GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03, Substantially Equivalent on 2001-11-27. Applicant: Gimmi GmbH.

Clearance details

Applicant: Gimmi GmbH
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2001-11-09
Decision date: 2001-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, Nh, NL

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.