510(k) K190829— Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

Substantially Equivalent

Wilson-Cook Medical Inc./Cook Endoscopy

Clearance details

Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-01
Decision date: 2019-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, 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.