BALLOON DILATION HELICAL STONE EXTRACT— 510(k) K831875

Name: FDA 510(k) clearance K831875
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Vpi

FDA 510(k) clearance K831875 for BALLOON DILATION HELICAL STONE EXTRACT, Substantially Equivalent on 1983-09-12. Applicant: Vpi. Device class: 2.

Clearance details

Applicant: Vpi
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1983-06-13
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K833762 — PERCUTANEOUS RETROGRADE NEPHROSTOMY1984-02-10

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.