VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)— 510(k) K261139
Substantially EquivalentFreyja Healthcare, LLC
FDA 510(k) clearance K261139 for VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103), Substantially Equivalent on 2026-08-13. Applicant: Freyja Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Freyja Healthcare, LLC
- 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
- Framingham, MA, US
Recent devices under product code GCJ
view all- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
- K261614 — LED LCD Monitor (OEV-271H)
- K261249 — Universal Seal (5-12 mm)
- K260710 — FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
More clearances from Freyja Healthcare, LLC
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.