Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K990213 ↗

FDA Product Code

EOB

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K992222 Active Cleared 26 Aug 1999

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• ENT Irrigating Pump (70327700)

  Class II

  FDA 510(k) K973286 Active Cleared 29 Sep 1997

• Smith & Nephew Pistons

  Class II

  FDA 510(k) K003214 Active Cleared 31 Oct 2000

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• What is the Hydraclear system used for in ENT procedures?

  The Hydraclear system is designed specifically for endoscopic sinus surgery. It uses a rotary peristaltic pump and disposable sheaths to irrigate and clear the surgical site, removing blood and tissue deposits in real time. This maintains visibility of the sinuscope lens, allowing surgeons to proceed with precision during procedures.

• How is the Hydraclear system supplied, and what components are included?

  The Hydraclear system is supplied as a reusable console, power supply, footswitch, and irrigation set, paired with single-use disposable sheaths. This modular setup ensures hygiene and convenience, as the reusable components are sterilized for reuse while the sheaths are designed for one-time use only.

• Are the reusable parts of the Hydraclear system sterilized for reuse?

  Yes, the reusable components—such as the pump console, power supply, and footswitch—are sterilized for reuse. This ensures compliance with medical standards while maintaining the system’s functionality across multiple procedures.

• Is the Hydraclear system suitable for flexible or rigid nasopharyngoscopes?

  The Hydraclear system is classified under FDA product code EOB and is intended for use with nasopharyngoscopes, whether flexible or rigid. Its design supports irrigation and suction capabilities that are compatible with these instruments during sinus surgery.

• What regulatory pathway does the Hydraclear system follow?

  The Hydraclear system holds FDA 510(k) clearance (K990213) and is classified as a Class II medical device under regulation 874.4760 for nasopharyngoscope applications. This clearance confirms its substantial equivalence to a predicate device and adherence to safety and performance standards.