GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM— 510(k) K072594
Substantially EquivalentGyrus 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.. Device class: 2.
Clearance details
- Applicant
- Gyrus Acmi, Inc.
- 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
- Southborough, MA, US
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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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.