SUCTION APPARATUS, POWERED BY COMP. AIR— 510(k) K781988

Name: FDA 510(k) clearance K781988
Creator: U.S. Food and Drug Administration
Published: 1978-12-12

Substantially Equivalent

Farley, W.T.

FDA 510(k) clearance K781988 for SUCTION APPARATUS, POWERED BY COMP. AIR, Substantially Equivalent on 1978-12-12. Applicant: Farley, W.T.. Device class: 2.

Clearance details

Applicant: Farley, W.T.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1978-11-27
Decision date: 1978-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE1996-12-31

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.