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Biofill cannula STS, Ø=3.5, L=150, 4H, Extraction

by Human Med AG

Ref 580089

Biofill cannula STS, Ø=3.5, L=150, 4H, Extraction (580089) is a device classified as Class IIa in the EU and Class II in the US made by Human Med AG, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-04260170881250), cleared under FDA 510(k) K082025 on 13 Aug 2008 and listed in FDA GUDID since 30 Jul 2025 (UDI-DI 04260170881250), active as of 7 Nov 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082025

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/MDD EUDAMED NumberB-04260170881250 Basic UDI-DI 04260170881250UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260170881250 UDI-DI Date30 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082025 Date13 Aug 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04260170881250 registered 2 Nov 2026 Active
  • FDA 510(k) K082025 decided 13 Aug 2008 Active
  • FDA GUDID UDI-DI 04260170881250 listed 30 Jul 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1251-2025 FDA Class II initiated 18 Oct 2024

    The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.

Timeline

4 dated events

  1. Cleared FDA 510(k) K082025
  2. Recall initiated FDA recalls Z-1251-2025
  3. Listed FDA GUDID 04260170881250
  4. Registered EUDAMED B-04260170881250

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  • Withdrawn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
Biofill Kanüle EUDAMED
Biofill cannula GUDID
Generic name
Liposuction system cannula, reusable
Device name
WAL cannula
Model / Ref / Catalog
580089, STS, Ø=3.5, L=150, 4H, Extraction
Primary DI / UDI-DI
04260170881250
Basic UDI-DI
B-04260170881250
510(k) Number
FDA product code
QPB
EMDN code
L030101 Suction and irrigation surgical cannulas and handpieces, reusable
GMDN term
Liposuction system cannula, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.5040
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
580089
GUDID
STS, Ø=3.5, L=150, 4H, Extraction
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: Liposuction system cannula, reusable

Cleared under the same submission (K082025)

and 8 more cleared under K082025

Similar devices in this category

Other devices filed under SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE.

Other devices from Human Med AG

See all devices from Human Med AG →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (18, all answered No)