TUBE GASTROSTOMY— 510(k) K903086

Name: FDA 510(k) clearance K903086
Creator: U.S. Food and Drug Administration
Published: 1990-11-20

Substantially Equivalent

Knight Medical, Inc.

FDA 510(k) clearance K903086 for TUBE GASTROSTOMY, Substantially Equivalent on 1990-11-20. Applicant: Knight Medical, Inc.. Device class: 2.

Clearance details

Applicant: Knight Medical, Inc.
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1990-07-12
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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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.