ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)— 510(k) K971528

Name: FDA 510(k) clearance K971528
Creator: U.S. Food and Drug Administration
Published: 1997-12-12

Substantially Equivalent

Fujinon, Inc.

FDA 510(k) clearance K971528 for ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY), Substantially Equivalent on 1997-12-12. Applicant: Fujinon, Inc.. Device class: 2.

Clearance details

Applicant: Fujinon, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1997-04-28
Decision date: 1997-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.