AED LAPAROSCOPE— 510(k) K993688
Substantially EquivalentNational Advanced Endoscopy Devices, Inc.
FDA 510(k) clearance K993688 for AED LAPAROSCOPE, Substantially Equivalent on 1999-12-06. Applicant: National Advanced Endoscopy Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- National Advanced Endoscopy Devices, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
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- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from National Advanced Endoscopy Devices, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.