HI-TEC CO2 INSUFFLATOR TYPE 1300— 510(k) K955477

Name: FDA 510(k) clearance K955477
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz

FDA 510(k) clearance K955477 for HI-TEC CO2 INSUFFLATOR TYPE 1300, Substantially Equivalent on 1997-08-06. Applicant: Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz. Device class: 2.

Clearance details

Applicant: Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1995-11-30
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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K930013 — CO2 INSUFFLATOR 11001995-04-14

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.