GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM— 510(k) K072594

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K072594 for GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM, Substantially Equivalent on 2007-12-13. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code FGA
Advisory panel: Gastroenterology, Urology
Date received: 2007-09-14
Decision date: 2007-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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Adverse events under product code FGA

product code FGA

Death: 7
Total: 7

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.