Omni-Guide Holdings, Inc.

Country / region:United States (US)

510(k) submissions

Filtered: GEX

Latest clearance

2023-04-21

Product codes

GEX

Cited as predicate

Product areas

FDA product code distribution

2 total · filtered by GEX

K number	Device name	Product code	Class	Decision date
K230819	OmniGuide RFID Surgical Laser Fibers	GEX	Class 2	2023-04-21
K220189	LISA Laser Surgical Fibers	GEX	Class 2	2022-04-29

K220189
LISA Laser Surgical Fibers
Omni-Guide Holdings, Inc.
K170366
Laser Peripherals, LLC Family of Bare Laser Fibers
Laser Peripherals, LLC

Omni-Guide Holdings, Inc. references 2 predicate/reference devices

K241643
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Wontech Co., Ltd.
K230819
OmniGuide RFID Surgical Laser Fibers
Omni-Guide Holdings, Inc.
K220793
InnoVoyce Laser Fiber
Innovoyce, LLC

3 submissions cite Omni-Guide Holdings, Inc. as a predicate