BUTTON REPLACEMENT GASTROSTOMY DEVICE— 510(k) K904779

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K904779 for BUTTON REPLACEMENT GASTROSTOMY DEVICE, Substantially Equivalent on 1991-01-18. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KGC
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-22
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksbury, MA, US

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Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.