swiftPro System (SWF-SPS); Swift System (SWF-SYS)— 510(k) K250718

Substantially Equivalent

Emblation Limited

FDA 510(k) clearance K250718 for swiftPro System (SWF-SPS); Swift System (SWF-SYS), Substantially Equivalent on 2025-08-08. Applicant: Emblation Limited.

Clearance details

Applicant: Emblation Limited
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2025-03-10
Decision date: 2025-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stirling, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.