APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR— 510(k) K041131
Substantially EquivalentApple Medical Corp.
FDA 510(k) clearance K041131 for APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR, Substantially Equivalent on 2004-05-13. Applicant: Apple Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Apple Medical Corp.
- 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
- Marlboro, MA, 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 Apple Medical Corp.
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.