ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,— 510(k) K031972

Substantially Equivalent

Asap Endoscopic Products GmbH

FDA 510(k) clearance K031972 for ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,, Substantially Equivalent on 2003-09-15. Applicant: Asap Endoscopic Products GmbH.

Clearance details

Applicant: Asap Endoscopic Products GmbH
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2003-06-26
Decision date: 2003-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

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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.