Skip to content

EZDilate BURS0510K

by Gyrus Acmi, Inc.

Ref BURS0510K

EZDilate BURS0510K is a device classified as Class IIa in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00821925033115), cleared under FDA 510(k) K132181 on 21 Oct 2013 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 00821925033115), active as of 25 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132181

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925033115 Basic UDI-DI 00821925033115UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925033115 UDI-DI Date5 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132181 Date21 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925033115 registered 7 Oct 2026 Active
  • FDA 510(k) K132181 decided 21 Oct 2013 Active
  • FDA GUDID UDI-DI 00821925033115 listed 5 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132181
  2. Listed FDA GUDID 00821925033115
  3. Registered EUDAMED B-00821925033115

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EZDilate
Generic name
Nephrostomy catheter
Device name
BURS0510K
Model / reference
BURS0510K
Primary DI / UDI-DI
00821925033115
Basic UDI-DI
B-00821925033115
510(k) Number
FDA product code
KOE
EMDN code
U030202 Ureteral dilators, with balloon
GMDN term
Nephrostomy catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5520
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Nephrostomy catheter

Cleared under the same submission (K132181)

and 7 more cleared under K132181

Similar devices in this category

Other devices filed under DEVICES FOR URETHRAL, URETERAL AND NEPHROSTOMIC DILATION.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)