WaveSelect

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: WaveSelect FDA UDI
Generic Name: Neurovascular embolization coil FDA UDI
Model / Reference: GW1410 FDA UDI

Identifiers

Primary DI / UDI-DI: 06945258302114 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

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Neurovascular embolization coil

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

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Also classified as Neurovascular embolization coil.

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HydroFill Helical — MICROVENTION INC. · Class II
TARGET — Stryker Corp. · Class II

Cleared under the same submission

K240871 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

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

Sources (1)

FDA UDI 6c34f431-217f-40f1-a39b-709729ed61d7 33 fields · synced Jun 1, 2026