FDA Import Refusal 799-9502919-7/22/1 — W CONCEPT

W CONCEPT — FEI 3038241170

The FDA refused shipment 799-9502919-7/22/1 from W CONCEPT (South Korea) on Jul 3, 2025. The refused product falls under Devices — FOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION. Cited charges: 118,3280,508 This firm has 1 other import refusal on record.

Refusal Details

Date
Jul 3, 2025
Country
South Korea
Product Category
Devices
Product Code
79QGM FOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION
Charges
118,3280,508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.