CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)— 510(k) K990127

Substantially Equivalent

Corpak Medsystems

FDA 510(k) clearance K990127 for CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD), Substantially Equivalent on 1999-02-10. Applicant: Corpak Medsystems.

Clearance details

Applicant: Corpak Medsystems
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1999-01-13
Decision date: 1999-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Wheeling, IL, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.