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WAL applicator

by Human Med AG 2 variants

WAL applicator (500001K-5) is a Class II device made by Human Med AG, cleared under FDA 510(k) K082025 on 13 Aug 2008 and listed in FDA GUDID since 30 Jul 2025 (UDI-DI 04260170880505), active as of 21 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K082025

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260170880505 UDI-DI Date30 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082025 Date13 Aug 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082025 decided 13 Aug 2008 Active
  • FDA GUDID UDI-DI 04260170880505 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

3 dated events

  1. Cleared FDA 510(k) K082025
  2. Recall initiated FDA recalls Z-1251-2025
  3. Listed FDA GUDID 04260170880505

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Surgical irrigation/aspiration tubing set
Model / Ref / Catalog
Single-use WAL Applicator, Short, L=300, for 20 cm cannulas, 500001K-5
Primary DI / UDI-DI
04260170880505
510(k) Number
FDA product code
QPB
GMDN term
Surgical irrigation/aspiration tubing set
Device class
Class II
Regulation number
878.5040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation/aspiration tubing set

Cleared under the same submission (K082025)

and 8 more cleared under K082025

Similar devices in this category

Other devices filed under Surgical irrigation/aspiration tubing set.

Other devices from Human Med AG

See all devices from Human Med AG →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (9, all answered No)