Disposable Veress Needles— 510(k) K232401

Substantially Equivalent

Hangzhou Kangji Medical Instrument Co., Ltd.

FDA 510(k) clearance K232401 for Disposable Veress Needles, Substantially Equivalent on 2023-12-14. Applicant: Hangzhou Kangji Medical Instrument Co., Ltd..

Clearance details

Applicant
Hangzhou Kangji Medical Instrument Co., Ltd.
Product code
Code HIF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code HIF

product code HIF
Death
19
Injury
578
Malfunction
5,639
Total
6,236

Source: openFDA MAUDE database, through . 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.