VCI INSUFLATOR FILTER W/ TUBING— 510(k) K930192

Name: FDA 510(k) clearance K930192
Creator: U.S. Food and Drug Administration
Published: 1994-03-02

Substantially Equivalent

Vital Concepts, Inc.

FDA 510(k) clearance K930192 for VCI INSUFLATOR FILTER W/ TUBING, Substantially Equivalent on 1994-03-02. Applicant: Vital Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Vital Concepts, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1993-01-14
Decision date: 1994-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, 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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K032832 — IRRIGATION SETS2003-09-26
K960616 — VITAFLOW SUCTION/ASPIRATION TUBING SET1996-05-06
K934382 — VCI SUCTION/IRRIGATION TUBING SET1994-02-01

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.