EASYGRIP FLO-41 Precision MIS Delivery System— 510(k) K193137
Substantially EquivalentBaxter Healthcare Corportation
FDA 510(k) clearance K193137 for EASYGRIP FLO-41 Precision MIS Delivery System, Substantially Equivalent on 2020-01-08. Applicant: Baxter Healthcare Corportation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corportation
- 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
- Round Lake, IL, US
Recent devices under product code GCJ
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- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- 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 Baxter Healthcare Corportation
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 K193137
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 K193137.
Data sourced from openFDA. This site is unofficial and independent of the FDA.