Omni-Guide Holdings, Inc.

Billerica, MA, US

Omni-Guide Holdings, Inc. appears in FDA device records in Billerica, MA. FDA records list 22 510(k) clearances between 2006-07-19 and 2023-04-21, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 22
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

2 names

FDA records resolved to Omni-Guide Holdings, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Domain Surgical, Inc.510(k), enforcement report, recall
Omniguide, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 22 510(k) clearances for Omni-Guide Holdings, Inc. between 2006 and 2023. The busiest year on record is 2014, with 4. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Omni-Guide Holdings, Inc., by decision year
Year	Clearances
2006	3
2007	3
2008	2
2009	2
2011	1
2012	1
2014	4
2015	1
2018	1
2019	1
2021	1
2022	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K230819	OmniGuide RFID Surgical Laser Fibers	GEX	Substantially Equivalent	2023-04-21
K220189	LISA Laser Surgical Fibers	GEX	Substantially Equivalent	2022-04-29
K203241	OmniGuide BeamPath OTO-U Fiber	GEX	Substantially Equivalent	2021-01-14
K183199	TRIO Handpiece	GEX	Substantially Equivalent	2019-05-02
K180993	Beacon Advanced CO2 Laser System	GEX	Substantially Equivalent	2018-06-28
K142229	Laparoscopic FMsealer	GEI	Substantially Equivalent	2015-01-02
K140378	FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT	GEX	Substantially Equivalent	2014-09-25
K141484	OPEN FMSEALER	GEI	Substantially Equivalent	2014-07-30
K140384	FMWAND HANDPIECE SE	GEI	Substantially Equivalent	2014-05-23
K130606	FMWAND FERROMAGNETIC SURGICAL SYSTEM	HGI	Substantially Equivalent	2014-01-03
K121881	DOMAIN SURGICAL SYSTEM	HGI	Substantially Equivalent	2012-10-18
K110439	DOMAIN SURGICAL SYSTEM	GEI	Substantially Equivalent	2011-07-18
K093451	OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP	GEX	Substantially Equivalent	2009-11-20
K093251	OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM	GEX	Substantially Equivalent	2009-10-29
K081939	OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY	GEX	Substantially Equivalent	2008-08-12
K073313	MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP	GEX	Substantially Equivalent	2008-01-02
K073409	OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM	GEX	Substantially Equivalent	2007-12-14
K070157	OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER	GEX	Substantially Equivalent	2007-02-01
K070071	OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER	GEX	Substantially Equivalent	2007-01-25
K063141	OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER	GEX	Substantially Equivalent	2006-11-29
K062423	OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM	GEX	Substantially Equivalent	2006-09-21
K061909	HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00	GEX	Substantially Equivalent	2006-07-19

Registered establishments

FDA registered establishments for Omni-Guide Holdings, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3005350457	3005350457	Omni-Guide Holdings, Inc.	43 Manning Road, Billerica, MA 01821 US	2026	GEI GEX HGI HQF

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0690-2017	FMsealer Open Shears. Model FM3001	Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.	Class II	2016-10-24	Terminated
Z-0453-2013	OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy	Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient	Class II	2012-11-05	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain