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FDA 510(k)

VereSee Optical Veres Needle System

K-Number: K232464 · 2024-05-02

ApplicantFreyja Healthcare, LLC
Decision Date2024-05-02
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VereSee Optical Veres Needle System 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 2024-05-02 under 510(k) number K232464. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VereSee Optical Veres Needle System?

VereSee Optical Veres Needle System is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is Freyja Healthcare, LLC. The 510(k) number is K232464.

When did VereSee Optical Veres Needle System receive FDA 510(k) clearance?

VereSee Optical Veres Needle System received FDA 510(k) clearance on 2024-05-02, under 510(k) number K232464.

Who is the listed applicant for VereSee Optical Veres Needle System?

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 System?

The FDA product code for VereSee Optical Veres Needle System is HIF.

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)K252640VereSee Optical Veres Needle and Endoscopic Camera

Related Devices (Code: HIF)

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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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