U-Blade Veress Needle— 510(k) K162648

Name: FDA 510(k) clearance K162648
Creator: U.S. Food and Drug Administration
Published: 2016-12-12

Substantially Equivalent

Tianjin Uwell Medical Device Manufacturing Co., Ltd.

FDA 510(k) clearance K162648 for U-Blade Veress Needle, Substantially Equivalent on 2016-12-12. Applicant: Tianjin Uwell Medical Device Manufacturing Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianjin Uwell Medical Device Manufacturing Co., Ltd.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-22
Decision date: 2016-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.