CO2 INSUFFLATOR 1100— 510(k) K930013

Name: FDA 510(k) clearance K930013
Creator: U.S. Food and Drug Administration
Published: 1995-04-14

Substantially Equivalent

Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz

FDA 510(k) clearance K930013 for CO2 INSUFFLATOR 1100, Substantially Equivalent on 1995-04-14. 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: 1993-01-04
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

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K955477 — HI-TEC CO2 INSUFFLATOR TYPE 13001997-08-06

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.