BILIARY DIALATOR— 510(k) K884714

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K884714 for BILIARY DIALATOR, Substantially Equivalent on 1989-09-29. Applicant: Primrose Medical, Inc..

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1988-11-08
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.