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Arrow IPN925057

by Teleflex Incorporated

Ref AI-01600

Arrow IPN925057 (AI-01600) is a device classified as Class IIa in the EU and Class I in the US made by Teleflex Incorporated, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI 08019020000000000000110JY), cleared under FDA 510(k) K895516 on 27 Dec 1989 and listed in FDA GUDID since 9 Nov 2022 (UDI-DI 10801902210408), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K895516

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000110JY Basic UDI-DI 10801902210408UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902210408 UDI-DI Date9 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK895516 Date27 Dec 1989DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000110JY registered 11 Aug 2026 Active
  • FDA 510(k) K895516 decided 27 Dec 1989 Active
  • FDA GUDID UDI-DI 10801902210408 listed 9 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K895516
  2. Listed FDA GUDID 10801902210408
  3. Registered EUDAMED 08019020000000000000110JY

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  • Withdrawn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
Percutaneous Cavity Drainage Catheterization Set EUDAMED
Arrow GUDID
Generic name
Incision/drainage kit
Device name
Percutaneous Cavity Drainage Catheter Product
Model / Ref / Catalog
AI-01600, IPN925057
Primary DI / UDI-DI
10801902210408
Basic UDI-DI
08019020000000000000110JY
510(k) Number
FDA product code
GBX
EMDN code
A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
GMDN term
Incision/drainage kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4200
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AI-01600
GUDID
IPN925057
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Incision/drainage kit

Cleared under the same submission (K895516)

and 8 more cleared under K895516

Similar devices in this category

Other devices filed under EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS).

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)