DeviceClearance

Product code KGC— Gastroenterology, Urology

PUMA-G System

Classification name
Tube, Gastro-Enterostomy
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
26
First cleared
Most recent

Market context for product code KGC

FDA has cleared 26 devices under product code KGC between 1978 and 2025, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code KGC

Adverse events under product code KGC

product code KGC
Death
7
Total
7

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 →

Recent clearances under product code KGC

Data sourced from openFDA. This site is unofficial and independent of the FDA.