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Double Flexible Tip Wire Guide With Hydrophilic Coating

by Cook Incorporated 2 variants

Ref RSPC-035145-DF-I-AQ

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

2 ongoing

Recall on shared 510(k) K171912; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171912↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0827002CINC011-042_A2WC Basic UDI-DI 00827002187924UDI-DIDate17 Nov 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK171912 Date19 Mar 2018IssuedStatusActive
United StatesGUDID listing GUDID Number00827002187924 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1835-2022 FDA Class II initiated 16 Aug 2022 on shared 510(k) K171912
    • Ongoing Z-1831-2022 FDA Class II initiated 16 Aug 2022 on shared 510(k) K171912

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Double Flexible Tip Wire Guide With Hydrophilic Coating EUDAMED
Roadrunner GUDID
Generic Name
Gastro-urological guidewire, single-use
Model / Ref / Catalog
RSPC-035145-DF-I-AQ, G18792
Primary DI / UDI-DI
00827002187924
Basic UDI-DI
0827002CINC011-042_A2WC
FDA Product Code
OCY
EMDN Code
U0601 Urological guidewires, hydrophilic
GMDN Term
Gastro-urological guidewire, single-use
Device Class
Class IIa 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
RSPC-035145-DF-I-AQ
GUDID
G18792
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003180
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

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

Other properties (18)

  • 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
  • Premarket Exempt: No
  • Serial Number: No