ASLAN MODULAR INSTRUMENT— 510(k) K954864
Substantially EquivalentAslan Medical Technologies, Ltd.
FDA 510(k) clearance K954864 for ASLAN MODULAR INSTRUMENT, Substantially Equivalent on 1996-02-09. Applicant: Aslan Medical Technologies, Ltd.. Device class: 2.
Clearance details
- Applicant
- Aslan Medical Technologies, Ltd.
- 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
- Kalamazoo, MI, 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 Aslan Medical Technologies, Ltd.
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.