WAL applicator

FDA UDI

Class II (US FDA UDI)

by Human Med AG

Identity

Trade Name: WAL applicator FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Device Name: WAL applicator, accessory for body-jet; suitable for WAL cannulas (30 cm), Single-use FDA UDI
Model / Reference: Single-use WAL Applicator for body-jet, L=300 FDA UDI
Description: WAL applicator, accessory for body-jet; suitable for WAL cannulas (30 cm), Single-use FDA UDI

Identifiers

Catalog Number: 500001-5 FDA UDI
Primary DI / UDI-DI: 04260170880048 FDA UDI
510(k) Number: K082025 FDA UDI
FDA Product Code: QPB FDA UDI
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical irrigation/aspiration tubing set

The WAL applicator is a single-use, implantable surgical irrigation/aspiration system designed for delivering irrigation solution and aspiration through flexible, double-lumen tubing. This innovative device features a collection of flexible, noninvasive tubing and associated items that provide twin conduits during surgery.

Similar devices

Also classified as Surgical irrigation/aspiration tubing set.

LAMIS Tubing — Mentor Texas LP · Class I
Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
Autofuse Tubing — Mentor Texas LP · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
Hysteroscopy set 2 spikes — Promepla · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Human Med AG

Sources (1)

FDA UDI 7d0dcb78-eaac-4fe7-8403-2dac587bdfe5 37 fields · synced Jul 25, 2026