Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) FDA UDI
Generic Name: Ultrasound aspiration biopsy procedure kit FDA UDI
Device Name: Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm, FNB needle FDA UDI
Model / Reference: EUS-22-1-FS1 FDA UDI
Description: Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm, FNB needle FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503534710 FDA UDI
510(k) Number: K212852 FDA UDI
FDA Product Code: FCG FDA UDI
GMDN Term: Ultrasound aspiration biopsy procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Dimensions & Sizes

Size: Needle Gauge — 22 Gauge FDA UDI

Category: Ultrasound aspiration biopsy procedure kit

Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Ultrasound aspiration biopsy procedure kit.

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Cleared under the same submission

K212852 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: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI 23a64e4a-459a-4e22-8e6b-a465ed567821 36 fields · synced Jun 8, 2026