Flexision

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 490104

by Intuitive Surgical, Inc.

Identity

Trade Name: Flexision Biopsy Needle, 19G EUDAMED
Flexision FDA UDI
Generic Name: General-purpose endoscopic needle, single-use FDA UDI
Device Name: Ion Biopsy Needle EUDAMED
Biopsy Needle, 19G FDA UDI
Model / Reference: 490104 EUDAMEDFDA UDI
Description: Biopsy Needle, 19G FDA UDI

Identifiers

Primary DI / UDI-DI: 00886874115978 EUDAMEDFDA UDI
Basic UDI-DI: 08868741211397V EUDAMED
FDA Product Code: EOQ FDA UDI
EMDN Code: A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
GMDN Term: General-purpose endoscopic needle, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 874.4680 FDA UDI
Medical Purpose: The Flexision Biopsy Needle is intended to retrieve tissue from a target structure. EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA 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

Category: General-purpose endoscopic needle, single-use

Flexision by Intuitive Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as General-purpose endoscopic needle, single-use.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Intuitive Surgical, Inc.

Sources (2)

FDA UDI 8e15c121-685d-4fae-aa36-21999bb7c429 33 fields · synced Jul 27, 2026
EUDAMED cd845e89-3c1f-44e6-a368-9ec18188d03f 61 fields · synced Jul 27, 2026