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.
Summary
Freyja Healthcare's VereSee lists six models: VER150, VER200, VER151, VER201, VER200C, and VER-100-103. It's filed under product code GCJ (Laparoscope, General & Plastic Surgery).
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Freyja filed from Framingham, Massachusetts. The decision came 128 calendar days after receipt (April 7 to August 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Freyja Healthcare, LLC
- Product code
- Product 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- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- 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)
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.