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Percutaneous Entry Set

by Cook Incorporated EUDAMED510(k)GUDID

Active United States and European Union

Ref 080000-ET510(k) K183035

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002190856 Basic UDI-DIDate27 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002190856 UDI-DIDate23 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESK 510(k) Substantially Equivalent — Kit · Traditional NumberK183035 Date17 May 2019ClearedStatusActive

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Cook
Generic Name
Nephrostomy catheter introduction needle
Model / Ref / Catalog
080000-ET, G19085
Primary DI / UDI-DI
00827002190856
Basic UDI-DI
B-00827002190856
510(k) Number
FDA Product Code
LJE
EMDN Code
U040203 Nephrostomy catheters
GMDN Term
Nephrostomy catheter introduction needle
Device Class
Class IIa EUDAMED
U 510(k)GUDID
Market of Registration
Germany
Advisory Committee
Unknown
FDA Decision
SESK Substantially Equivalent — Kit
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
080000-ET
510(k)
n/a
GUDID
G19085
Device ClassEUDAMED
Class IIa
510(k)
U
GUDID
U

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 (16)

  • Implantable: No
  • 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