WAL applicator
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Overview
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.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04260170880048 | Date30 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082025 | Date13 Aug 2008 | StatusActive |
Official records
- AccessGUDID record 04260170880048
- FDA 510(k) database K082025
Across registries
- FDA 510(k) K082025 decided 13 Aug 2008 Active
- FDA GUDID UDI-DI 04260170880048 listed 30 Jul 2025 Listed
Recalls
-
- Ongoing Z-1251-2025
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
- Cleared FDA 510(k) K082025
- Recall initiated FDA recalls Z-1251-2025
- Listed FDA GUDID 04260170880048
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Surgical irrigation/aspiration tubing set
- Model / Ref / Catalog
- Single-use WAL Applicator for body-jet, L=300, 500001-5
- Primary DI / UDI-DI
- 04260170880048
- 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
Similar devices in this category
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- Disposable EVA Irrigation and Aspiration Tubing 8110.IAD01 by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- WHITESTAR SIGNATURE OPO73 by Johnson & Johnson Surgical Vision, Inc.
- CrossFlow 0450000300 0450-000-300 by Stryker Corp.
- MicroAire® PAL-1200 by MicroAire Surgical Instruments LLC
- Disposable EVA Double Irrigation Line with Air Exchange 8110.DIL01 by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Diego Elite TS200S by Gyrus Acmi, Inc.
- CUSA® Clarity C7300EA by INTEGRA LIFESCIENCES (IRELAND) LIMITED
- SOVEREIGN COMPACT OPO61 by Johnson & Johnson Surgical Vision, Inc.
- Suction Irrigation System C6003 by APPLIED MEDICAL RESOURCES CORP.