PORGES STEPPED NEOPLEX DILATOR— 510(k) K883526

Substantially Equivalent

Porges Corp.

FDA 510(k) clearance K883526 for PORGES STEPPED NEOPLEX DILATOR, Substantially Equivalent on 1988-10-28. Applicant: Porges Corp..

Clearance details

Applicant: Porges Corp.
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1988-08-18
Decision date: 1988-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

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.