ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY— 510(k) K895182
Substantially EquivalentAdvanced Surgical Intervention, Inc.
FDA 510(k) clearance K895182 for ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY, Substantially Equivalent on 1989-10-24. Applicant: Advanced Surgical Intervention, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Surgical Intervention, Inc.
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
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More clearances from Advanced Surgical Intervention, Inc.
view allAdverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
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.