IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2— 510(k) K071883

Substantially Equivalent

Cyden Limited

FDA 510(k) clearance K071883 for IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2, Substantially Equivalent on 2008-01-23. Applicant: Cyden Limited.

Clearance details

Applicant: Cyden Limited
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2007-07-09
Decision date: 2008-01-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Swansea, Wales, GB

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.