Xwire

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: XWIRE FDA UDI
Generic Name: Gastro-urological guidewire, single-use FDA UDI
Device Name: XWire® Biliary Guidewire 450 cm Angled Tip, .89 mm Guidewire Length, Stiff Wire, .035" O.D. FDA UDI
Model / Reference: 035450AS FDA UDI
Description: XWire® Biliary Guidewire 450 cm Angled Tip, .89 mm Guidewire Length, Stiff Wire, .035" O.D. FDA UDI

Identifiers

Catalog Number: 035450AS FDA UDI
Primary DI / UDI-DI: 20653405053948 FDA UDI
510(k) Number: K011759 FDA UDI
FDA Product Code: OCY FDA UDI
GMDN Term: Gastro-urological guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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: Outer Diameter — 0.035 Inch FDA UDI
Length — 450 Centimeter FDA UDI
Outer Diameter — 0.89 Millimeter FDA UDI

Category: Gastro-urological guidewire, single-use

Xwire by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastro-urological guidewire, single-use.

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Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Optimos™ Guidewire — Taewoong Medical · Class II

Cleared under the same submission

K011759 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: Conmed Corporation

Sources (1)

FDA UDI a8faef54-cd47-4562-a72a-35dc72c3b5aa 37 fields · synced May 30, 2026