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FDA 510(k)

VereSee Optical Veres Needle and Endoscopic Camera

K-Number: K252640 · 2025-10-20

Decision Date2025-10-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VereSee Optical Veres Needle and Endoscopic Camera 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 2025-10-20 under 510(k) number K252640. 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 Optical Veres Needle and Endoscopic Camera?

VereSee Optical Veres Needle and Endoscopic Camera is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Freyja Healthcare, LLC. The 510(k) number is K252640.

When did VereSee Optical Veres Needle and Endoscopic Camera receive FDA 510(k) clearance?

VereSee Optical Veres Needle and Endoscopic Camera received FDA 510(k) clearance on 2025-10-20, under 510(k) number K252640.

Who is the listed applicant for VereSee Optical Veres Needle and Endoscopic Camera?

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 Optical Veres Needle and Endoscopic Camera?

The FDA product code for VereSee Optical Veres Needle and Endoscopic Camera 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.

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.

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.