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 a medical device manufactured by Omni-Guide Holdings, Inc.. It received FDA 510(k) clearance on 2023-04-21 under approval 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. It is manufactured by Omni-Guide Holdings, Inc.. The 510(k) number is K230819.
When was OmniGuide RFID Surgical Laser Fibers approved by the FDA?
OmniGuide RFID Surgical Laser Fibers received FDA 510(k) clearance on 2023-04-21, under approval number K230819.
What company makes OmniGuide RFID Surgical Laser Fibers?
OmniGuide RFID Surgical Laser Fibers is manufactured by Omni-Guide Holdings, Inc..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.