Who else makes this device?

Name: Licox®
Brand: Licox®

Licox® · Device, Monitoring, Intracranial Pressure → Neurology

5manufacturers in China registered for this device type

38catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GWM
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
PAN-International Precision Electronic Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Shanghai Wilpower Industrial Co., Ltd.	Shanghai	Shanghai	Exporter	33

Record

Regulatory record for Licox®
Listed by	GMS, Gesellschaft für medizinische Sondentechnik mbH
FDA product code	GWM
Device type	Device, Monitoring, Intracranial Pressure
Device class	Class 2
Regulation	21 CFR 882.1620
510(k)	K002765
Record published	2017-10-09
Record revised	2025-11-24 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Handling environment temperature 2 to 10 °C; Special storage condition: Keep Away From Sunlight
Distribution end date	2023-12-04
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Licox®
Catalogue number	Size	Status
D72K	250 mm x 180 mm	Withdrawn
D11	250 mm x 180 mm	Withdrawn
D72	250 mm x 180 mm	Withdrawn
D6	250 mm x 180 mm	Withdrawn
IM3ST	130 mm x 50 mm x 313 mm	Withdrawn
BC10TV	250 mm x 180 mm	Withdrawn
PMOFC	250 mm x 180 mm	Withdrawn
BC10PA	250 mm x 180 mm	Withdrawn
IM2	130 mm x 35 mm x 313 mm	Withdrawn
BC10PMO	250 mm x 180 mm	Withdrawn
IM3	130 mm x 35 mm x 313 mm	Withdrawn
D7VL	250 mm x 180 mm	Withdrawn
IM2S	130 mm x 35 mm x 313 mm	Withdrawn
D72B	250 mm x 180 mm	Withdrawn
CC1SB	130 mm x 35 mm x 313 mm	Withdrawn
IT2	130 mm x 35 mm x 313 mm	Withdrawn
BC10	173 mm x 260 mm x 45 mm	Withdrawn
CC1P1	130 mm x 35 mm x 313 mm	Withdrawn
D73	250 mm x 180 mm	Withdrawn
A10US	113mm x 87mm x 60mm	Withdrawn
BC10S	250 mm x 180 mm	Withdrawn
PMOBOX	320 mm x 285 mm x 80 mm	Withdrawn
D73B	250 mm x 180 mm	Withdrawn
D73K	250 mm x 180 mm	Withdrawn
BC10R	250 mm x 180 mm	Withdrawn
VK52	130 mm x 35 mm x 313 mm	Withdrawn
BC10TA	250 mm x 180 mm	Withdrawn
IP1P	130 mm x 35 mm x 313 mm	Withdrawn
PMOCAB	250 mm x 180 mm	Withdrawn
IP1	130 mm x 35 mm x 313 mm	Withdrawn
IM1S	130 mm x 35 mm x 313 mm	Withdrawn
IP2	130 mm x 35 mm x 313 mm	Withdrawn
PMOPST	250 mm x 180 mm	Withdrawn
BC10PV	250 mm x 180 mm	Withdrawn
IM1	130 mm x 35 mm x 313 mm	Withdrawn
IP2P	130 mm x 35 mm x 313 mm	Withdrawn
C8B	130 mm x 35 mm x 313 mm	Withdrawn
IM3S	130 mm x 35 mm x 313 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sophysa	Sophysa	32
Becker®	Medtronic PS Medical	31
Codman	Cerenovus, Inc.	29
Device, Monitoring, Intracranial Pressure	Medtronic PS Medical	28
Exacta™	Medtronic PS Medical	28
Braincare	Braincare Desenvolvimento E Inovacao Tecnologica SA	24
Camino®	Integra Lifesciences (Ireland) Limited	20
Codman®	Integra LifeSciences Production Corporation	19
Integra®	Integra Lifesciences (Ireland) Limited	17
Aura	Branchpoint & Aura Development LLC	17
Natus	Natus Medical Incorporated	15
Duet®	Medtronic PS Medical	14

Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Licox®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Integra Lifesciences Corporation	510(k) number	2014-11-07	Class II	Device Design	Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.	2,506 units	2015-08-11
Integra Lifesciences Corporation	510(k) number	2010-12-17	Not classified	Nonconforming Material/Component	Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.	26 units	2012-11-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Licox®