U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE— 510(k) K955181

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K955181 for U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE, Substantially Equivalent on 1996-06-05. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1995-11-13
Decision date: 1996-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, 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.