REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES— 510(k) K072753

Substantially Equivalent

Rg Medical USA

FDA 510(k) clearance K072753 for REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES, Substantially Equivalent on 2008-01-25. Applicant: Rg Medical USA.

Clearance details

Applicant: Rg Medical USA
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2007-09-27
Decision date: 2008-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

Download summary PDF View 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, 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.