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Synxess

FDA UDI

Class II (US FDA UDI)

by Enlight Medical Technologies (Shenzhen) Co., Ltd.

Identity

Trade Name
Synxess FDA UDI
Generic Name
Neurovascular embolization coil FDA UDI
Device Name
This product is comprised of a stainless steel core wire with distal platinum tungsten coil and proximal stainless steel coil, and includes a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The diameters of the guidewires are listed in the table below. The guidewires are compatible with devices with inner diameters (IDs) specified in the table below. The distal 30 mm of the guidewire tip is radiopaque. Confirm the compatibility of the guidewire diameter with the interventional device before use. For lubricity, the distal 300 mm of the device is coated with hydrophilic coating and the proximal portion of the guidewire is coated with hydrophobic polytetrafluoroethylene (PTFE).The shaping mandrel included with the guidewire can be used to shape the tip of the guidewire as appropriate. When shaping the tip, carefully crimp it while the surface is wet. The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of the torque device facilitates guidewire placement into the target vessel by manipulation of the guidewire tip. FDA UDI
Model / Reference
GW1010 FDA UDI
Description
This product is comprised of a stainless steel core wire with distal platinum tungsten coil and proximal stainless steel coil, and includes a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The diameters of the guidewires are listed in the table below. The guidewires are compatible with devices with inner diameters (IDs) specified in the table below. The distal 30 mm of the guidewire tip is radiopaque. Confirm the compatibility of the guidewire diameter with the interventional device before use. For lubricity, the distal 300 mm of the device is coated with hydrophilic coating and the proximal portion of the guidewire is coated with hydrophobic polytetrafluoroethylene (PTFE).The shaping mandrel included with the guidewire can be used to shape the tip of the guidewire as appropriate. When shaping the tip, carefully crimp it while the surface is wet. The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of the torque device facilitates guidewire placement into the target vessel by manipulation of the guidewire tip. FDA UDI

Identifiers

Primary DI / UDI-DI
06945258302015 FDA UDI
510(k) Number
K240871 FDA UDI
FDA Product Code
MOF FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neurovascular embolization coil

Synxess by Enlight Medical Technologies (Shenzhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurovascular embolization coil.

Cleared under the same submission

K240871 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Enlight Medical Technologies (Shenzhen) Co., Ltd.

Sources (1)

  • FDA UDI 3c51fbcb-a0f5-4f97-830b-3c23f0100648 34 fields · synced Jun 6, 2026