OEM MULTI-VAC POWERED SUCTION PUMP— 510(k) K924570

Name: FDA 510(k) clearance K924570
Creator: U.S. Food and Drug Administration
Published: 1993-08-05

Substantially Equivalent

Oem Medical Div.

FDA 510(k) clearance K924570 for OEM MULTI-VAC POWERED SUCTION PUMP, Substantially Equivalent on 1993-08-05. Applicant: Oem Medical Div.. Device class: 2.

Clearance details

Applicant: Oem Medical Div.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1992-09-10
Decision date: 1993-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

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

More clearances from Oem Medical Div.

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K761297 — MOUTHPIECE SEAL1977-01-03

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.