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Acrobat 2 Calibrated Tip Wire Guide

by Wilson-Cook Medical, Inc. 10 variants

Ref AWG2-35-260-A510(k) K142950

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142950↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00827002476158 Basic UDI-DI 00827002476158UDI-DIDate6 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00827002476158 Basic UDI-DI 00827002476158UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002476158 UDI-DI Date6 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK142950 Date5 Nov 2014ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Acrobat® 2 Calibrated Tip Wire Guide EUDAMED
Acrobat GUDID
Generic Name
Gastro-urological guidewire, single-use
Device Name
Wire Guides
Model / Ref / Catalog
AWG2-35-260-A, G47615
Primary DI / UDI-DI
00827002476158
Basic UDI-DI
B-00827002476158, 0827002WCM00000000009MS
FDA Product Code
OCY
EMDN Code
G0380 Digestive endoscopy devices - accessories
GMDN Term
Gastro-urological guidewire, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AWG2-35-260-A
GUDID
G47615
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002658
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

From the manufacturer

Manufacturer's product page: Acrobat® 2 Calibrated Tip Wire Guide

Related devices

Category: Gastro-urological guidewire, single-use

Other devices from Wilson-Cook Medical, Inc.

See all devices from Wilson-Cook Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No