Ophthalmic PAO Valve

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K882536 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Look Irrigating/Aspirating Cannula W/Teflon Sheath

  Class I

  FDA 510(k) K872884 Active Cleared 10 Aug 1987

• Look Irrigating Cystotomes

  Class I

  FDA 510(k) K870439 Active Cleared 20 Feb 1987

• Look Viscodissector

  Class II

  FDA 510(k) K913530 Active Cleared 21 Oct 1991

• Sterile Black Monofilament Nylon Non-Absor. Suture

  Class II

  FDA 510(k) K903029 Active Cleared 25 Oct 1990

• Look Retrobulbar Needles

  Class I

  FDA 510(k) K870902 Active Cleared 20 Mar 1987

• Gut Sutures

  Class II

  FDA 510(k) K896554 Active Cleared 31 May 1990

See all devices from Look, Inc. →

• What is the Ophthalmic PAO Valve used for in surgical procedures?

  The Ophthalmic PAO Valve is designed as a syringe check valve to regulate and control fluid flow during ophthalmic surgeries. Its primary function is to deliver liquids with precision while preventing backflow, which is critical in procedures like intraocular injections or irrigation. The valve’s construction allows for controlled pressure adjustments, minimizing contamination risks and ensuring sterility in sterile surgical environments.

• Is the Ophthalmic PAO Valve intended for single-use or reuse?

  The Ophthalmic PAO Valve is explicitly supplied as a single-use component. This design ensures sterility and reduces the risk of cross-contamination between patients, aligning with standard aseptic techniques required in surgical settings. Reuse is not recommended or supported by the manufacturer.

• What regulatory approval does the Ophthalmic PAO Valve hold?

  The Ophthalmic PAO Valve holds an FDA 510(k) clearance under the product code FMF, with the clearance number K882536. It was granted under the Traditional clearance type and is classified under FDA regulation 880.5860. The device is intended for general hospital use, and no third-party review was involved in its clearance process.

• How should the Ophthalmic PAO Valve be stored before use?

  While the provided data does not specify storage conditions explicitly, the Ophthalmic PAO Valve is intended for sterile surgical environments. As a single-use device, it should be stored in its original packaging until use, protected from contamination and extreme temperatures. Always follow manufacturer guidelines or local protocols for sterile medical devices.

• What distinguishes the Ophthalmic PAO Valve from other syringe valves?

  The Ophthalmic PAO Valve is specifically engineered for ophthalmic procedures, offering precise fluid control and check-valve functionality to prevent backflow during delicate interventions. Its design emphasizes sterility and minimal contamination risk, making it suitable for intraocular injections or irrigation where accuracy and safety are paramount. The valve’s controlled pressure adjustments further differentiate it for applications requiring meticulous fluid management.