ASAP MUITISCOPE— 510(k) K121261

Substantially Equivalent

Asap Endoscopic Products GmbH

FDA 510(k) clearance K121261 for ASAP MUITISCOPE, Substantially Equivalent on 2013-01-08. Applicant: Asap Endoscopic Products GmbH.

Clearance details

Applicant: Asap Endoscopic Products GmbH
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2012-04-26
Decision date: 2013-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, Nh, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.