CERULLO SUCTION REGULATOR— 510(k) K880704

Name: FDA 510(k) clearance K880704
Creator: U.S. Food and Drug Administration
Published: 1988-03-29

Substantially Equivalent

Aesculap Instruments Corp.

FDA 510(k) clearance K880704 for CERULLO SUCTION REGULATOR, Substantially Equivalent on 1988-03-29. Applicant: Aesculap Instruments Corp.. Device class: 2.

Clearance details

Applicant: Aesculap Instruments Corp.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1988-02-22
Decision date: 1988-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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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.