MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY— 510(k) K874936

Substantially Equivalent

Medsurg Industries, Inc.

FDA 510(k) clearance K874936 for MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY, Substantially Equivalent on 1988-04-14. Applicant: Medsurg Industries, Inc.. Device class: 2.

Clearance details

Applicant
Medsurg Industries, Inc.
Product code
Code KNT
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Herndon, VA, US
Download summary PDFView on FDA.gov ↗

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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, through . 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.