SubQKath Catheter and Needle Set— 510(k) K193664

Substantially Equivalent

Hk Surgical

FDA 510(k) clearance K193664 for SubQKath Catheter and Needle Set, Substantially Equivalent on 2020-09-09. Applicant: Hk Surgical.

Clearance details

Applicant: Hk Surgical
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2019-12-31
Decision date: 2020-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.