ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE— 510(k) K031141

Substantially Equivalent

Asap Endoscopic Products GmbH

FDA 510(k) clearance K031141 for ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE, Substantially Equivalent on 2003-06-30. Applicant: Asap Endoscopic Products GmbH.

Clearance details

Applicant: Asap Endoscopic Products GmbH
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2003-04-10
Decision date: 2003-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.