DeviceClearance

Percutaneous Nephroscope System— 510(k) K232370

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K232370 for Percutaneous Nephroscope System, Substantially Equivalent on 2024-05-01. Applicant: Karl Storz SE & CO. KG. Device class: 2.

Clearance details

Applicant
Karl Storz SE & CO. KG
Product code
Code FGA
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuttlingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FGA

product code FGA
Death
7
Total
7

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K232370

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232370.

Data sourced from openFDA. This site is unofficial and independent of the FDA.