ENDOASSIST— 510(k) K043284
Substantially EquivalentArmstrong Healthcare Limited
FDA 510(k) clearance K043284 for ENDOASSIST, Substantially Equivalent on 2005-02-25. Applicant: Armstrong Healthcare Limited. Device class: 2.
Clearance details
- Applicant
- Armstrong Healthcare Limited
- 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
- High Wycombe, GB
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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 Armstrong Healthcare Limited
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.