SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty— 510(k) K171568

Substantially Equivalent

Hans Biomed Corporation

FDA 510(k) clearance K171568 for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty, Substantially Equivalent on 2018-02-22. Applicant: Hans Biomed Corporation.

Clearance details

Applicant: Hans Biomed Corporation
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2017-05-30
Decision date: 2018-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.