ABCO SUCTION CATHETER & KITS W/GLOVE&CUP— 510(k) K800234

Substantially Equivalent

Abco Dealers, Inc.

FDA 510(k) clearance K800234 for ABCO SUCTION CATHETER & KITS W/GLOVE&CUP, Substantially Equivalent on 1980-02-26. Applicant: Abco Dealers, Inc..

Clearance details

Applicant: Abco Dealers, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1980-02-05
Decision date: 1980-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.