MODIFICATION TO OPTICAL SEPARATOR SYSTEM— 510(k) K041795
Substantially EquivalentApplied Medical Resources Corp.
FDA 510(k) clearance K041795 for MODIFICATION TO OPTICAL SEPARATOR SYSTEM, Substantially Equivalent on 2004-09-14. Applicant: Applied Medical Resources Corp.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources 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
- Rancho Santa, 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 Applied Medical Resources 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 →
Recalls naming K041795
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041795.
Data sourced from openFDA. This site is unofficial and independent of the FDA.