K884712

Substantially Equivalent

ESOPHAGEAL AND PYLORIC BALLOON DIALATORS

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

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.