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FDA 510(k)

OmniGuide RFID Surgical Laser Fibers

K-Number: K230819 · 2023-04-21

ApplicantOmni-Guide Holdings, Inc.
Decision Date2023-04-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OmniGuide RFID Surgical Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Guide Holdings, Inc.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K230819. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniGuide RFID Surgical Laser Fibers?

OmniGuide RFID Surgical Laser Fibers is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Omni-Guide Holdings, Inc.. The 510(k) number is K230819.

When did OmniGuide RFID Surgical Laser Fibers receive FDA 510(k) clearance?

OmniGuide RFID Surgical Laser Fibers received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230819.

Who is the listed applicant for OmniGuide RFID Surgical Laser Fibers?

The FDA 510(k) record lists Omni-Guide Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniGuide RFID Surgical Laser Fibers?

The FDA product code for OmniGuide RFID Surgical Laser Fibers is GEX. This falls under the Gastroenterology category.

Other records listing Omni-Guide Holdings, Inc. 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.

K220189LISA Laser Surgical Fibers

Related Devices (Code: GEX)

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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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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