DISPOSABLE FILTERED INSUFFLATION TUBING SET— 510(k) K941685

Name: FDA 510(k) clearance K941685
Creator: U.S. Food and Drug Administration
Published: 1994-05-26

Substantially Equivalent

Blue Planet Industries, Inc.

FDA 510(k) clearance K941685 for DISPOSABLE FILTERED INSUFFLATION TUBING SET, Substantially Equivalent on 1994-05-26. Applicant: Blue Planet Industries, Inc.. Device class: 2.

Clearance details

Applicant: Blue Planet Industries, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1994-04-06
Decision date: 1994-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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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.