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Cope

by Cook Incorporated

Ref ULT10.2-10.2-28-NUCL-B-RH, ULT8.5-8.5-20-NUCL-B-RH, ULT8.5-8.5-24-NUCL-B-RH, ULT10.2-10.2-24-NUCL-B-RH, ULT8.5-8.5-28-NUCL-B-RH510(k) K191498

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

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) K191498↗

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/MDD EUDAMED NumberB-00827002481688 Basic UDI-DI Date3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002481688 UDI-DI Date13 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESK 510(k) Substantially Equivalent — Kit · Traditional NumberK191498 Date29 Jan 2020ClearedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Nephrostomy catheter
Model / Ref / Catalog
ULT10.2-10.2-28-NUCL-B-RH, ULT8.5-8.5-20-NUCL-B-RH, ULT8.5-8.5-24-NUCL-B-RH, ULT10.2-10.2-24-NUCL-B-RH, ULT8.5-8.5-28-NUCL-B-RH, G48176, G48164, G48183, G48168, G48171
Primary DI / UDI-DI
00827002481688, 00827002481718, 00827002481763, 00827002481640, 00827002481831
Basic UDI-DI
B-00827002481688, B-00827002481718, B-00827002481763, B-00827002481640, B-00827002481831
510(k) Number
FDA Product Code
LJE 510(k)
FAD GUDID
EMDN Code
U040203 Nephrostomy catheters
GMDN Term
Nephrostomy catheter
Device Class
Class IIb EUDAMED
U 510(k)
Class II GUDID
Regulation Number
876.4620
EU market of registration
Germany
Advisory Committee
Unknown
FDA Decision
SESK Substantially Equivalent — Kit
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

3 sources · 5 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
ULT10.2-10.2-28-NUCL-B-RH
ULT8.5-8.5-20-NUCL-B-RH
ULT8.5-8.5-24-NUCL-B-RH
ULT10.2-10.2-24-NUCL-B-RH
ULT8.5-8.5-28-NUCL-B-RH
510(k)
—
GUDID
G48176
G48164
G48183
G48168
G48171
510(k) NumberEUDAMED
—
510(k)
K191498
GUDID
K171603
FDA Product CodeEUDAMED
—
510(k)
LJE
GUDID
FAD
Device ClassEUDAMED
Class IIb
510(k)
U
GUDID
Class II
ImplantableEUDAMED
Yes
510(k)
—
GUDID
No

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
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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