K924102

Substantially Equivalent

NEEDLE

Applicant: United States Endoscopy Group, Inc.
Product code: FBK
Advisory panel: Gastroenterology, Urology
Date received: 1992-08-13
Decision date: 1992-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waite Hill, OH, US

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.