PORGES SCLEROTHERAPY NEEDLES— 510(k) K896424

Name: FDA 510(k) clearance K896424
Creator: U.S. Food and Drug Administration
Published: 1990-01-26

Substantially Equivalent

Porges Corp.

FDA 510(k) clearance K896424 for PORGES SCLEROTHERAPY NEEDLES, Substantially Equivalent on 1990-01-26. Applicant: Porges Corp.. Device class: 2.

Clearance details

Applicant: Porges Corp.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-08
Decision date: 1990-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

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K896503 — PORGES ERCP CATHETERS1990-01-30
K896505 — PORGES UNIVERSAL HANDLES1990-01-30
K896425 — PORGES CYTOLOGY BRUSHES1990-01-29

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.