CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR— 510(k) K920114

Name: FDA 510(k) clearance K920114
Creator: U.S. Food and Drug Administration
Published: 1992-04-06

Substantially Equivalent

Spiess Design, Inc.

FDA 510(k) clearance K920114 for CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR, Substantially Equivalent on 1992-04-06. Applicant: Spiess Design, Inc.. Device class: 2.

Clearance details

Applicant: Spiess Design, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1992-01-10
Decision date: 1992-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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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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.