ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0— 510(k) K032822

Substantially Equivalent

Asap Endoscopic Products GmbH

FDA 510(k) clearance K032822 for ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0, Substantially Equivalent on 2004-01-08. Applicant: Asap Endoscopic Products GmbH.

Clearance details

Applicant: Asap Endoscopic Products GmbH
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2003-09-10
Decision date: 2004-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.