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FDA 510(k)

VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)

K-Number: K261139 · 2026-08-13

ApplicantFreyja Healthcare, LLC
Decision Date2026-08-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) is the device name listed in this FDA 510(k) record. The listed applicant is Freyja Healthcare, LLC. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K261139. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)?

VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Freyja Healthcare, LLC. The 510(k) number is K261139.

When did VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) receive FDA 510(k) clearance?

VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) received FDA 510(k) clearance on 2026-08-13, under 510(k) number K261139.

Who is the listed applicant for VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)?

The FDA 510(k) record lists Freyja Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)?

The FDA product code for VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) is GCJ.

Other records listing Freyja Healthcare, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252640VereSee Optical Veres Needle and Endoscopic CameraK232464VereSee Optical Veres Needle System

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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