SUCTION CONNECTING TUBING— 510(k) K914601

Name: FDA 510(k) clearance K914601
Creator: U.S. Food and Drug Administration
Published: 1992-02-07

Substantially Equivalent

Bemis Mfg. Co.

FDA 510(k) clearance K914601 for SUCTION CONNECTING TUBING, Substantially Equivalent on 1992-02-07. Applicant: Bemis Mfg. Co.. Device class: 2.

Clearance details

Applicant: Bemis Mfg. Co.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1991-10-11
Decision date: 1992-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan Falls, WI, US

Download summary PDF View on FDA.gov ↗

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K964858 — BEMIS TWO GALLON CHEMOTHERAPY CONTAINER1997-02-11
K960525 — BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)1996-03-28
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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.