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AMT Introducer E4-5000

by Applied Medical Technology, Inc.

Ref E4-5000

AMT Introducer E4-5000 is a peritoneal catheter stylet (EU MDR Class I; FDA Class II; FDA product code KNT, Tubes, Gastrointestinal (And Accessories)) made by Applied Medical Technology, Inc., registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 08420711INTRODUCER49), cleared under FDA 510(k) K042300 on 25 Oct 2004 and listed in FDA GUDID since 19 Jul 2024 (UDI-DI 00842071133184), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K042300

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08420711INTRODUCER49 Basic UDI-DI 00842071133184UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071133184 UDI-DI Date19 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042300 Date25 Oct 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08420711INTRODUCER49 registered 30 Apr 2026 Active
  • FDA 510(k) K042300 decided 25 Oct 2004 Active
  • FDA GUDID UDI-DI 00842071133184 listed 19 Jul 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K042300
  2. Listed FDA GUDID 00842071133184
  3. Registered EUDAMED 08420711INTRODUCER49

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AMT Introducer
Generic name
Peritoneal catheter stylet
Device name
Introducer/Stiffener
Model / Ref / Catalog
E4-5000, 4-5000
Primary DI / UDI-DI
00842071133184
Basic UDI-DI
08420711INTRODUCER49
510(k) Number
FDA product code
KNT
EMDN code
G020299 Gastrointestinal feeding/aspiration tubes - other
GMDN term
Peritoneal catheter stylet
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5980
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Peritoneal catheter stylet

Cleared under the same submission (K042300)

and 2 more cleared under K042300

Similar devices in this category

Other devices filed under GASTROINTESTINAL FEEDING/ASPIRATION TUBES.

Other devices from Applied Medical Technology, Inc.

See all devices from Applied Medical Technology, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)