RECEPTAL SAF-GARD(TM) SYSTEM— 510(k) K885208

Unknown

Abbott Laboratories

FDA 510(k) clearance K885208 for RECEPTAL SAF-GARD(TM) SYSTEM, Unknown on 1989-03-17. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1988-12-19
Decision date: 1989-03-17
Decision: Unknown
Clearance type: Traditional
Location: Abbott Park, IL, US

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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.