NO. 86500 Endoscopic Jet Washer

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

510(k) Number

K892426 ↗

FDA Product Code

OCX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Superior Healthcare Group, Inc. →

• What is the primary purpose of the NO. 86500 Endoscopic Jet Washer in clinical procedures?

  The NO. 86500 Endoscopic Jet Washer is designed specifically for flushing and clearing fluid from endoscopic instruments during gastrointestinal or urological procedures. It uses a high-pressure jet stream to remove debris, blood, or residual fluids, ensuring clear visualization of the instruments and maintaining their hygiene throughout the procedure.

• Is the NO. 86500 Endoscopic Jet Washer intended for single-use or repeated use?

  The NO. 86500 Endoscopic Jet Washer is explicitly intended for single-use in clinical settings. This design choice helps ensure patient safety and hygiene by preventing cross-contamination between procedures.

• How should the NO. 86500 Endoscopic Jet Washer be stored before use?

  The device should be stored in a clean, dry environment prior to use. Since it is non-sterile as supplied, proper storage conditions help maintain its functionality and prevent contamination before clinical application.

• What types of endoscopic procedures is this device compatible with?

  The NO. 86500 Endoscopic Jet Washer is compatible with standard endoscopic procedures in gastroenterology and urology, as indicated by its FDA clearance and advisory committee classification. It is designed to assist in clearing instruments used during these specialties.

• What regulatory pathway did the NO. 86500 Endoscopic Jet Washer follow for FDA clearance?

  The device received FDA 510(k) clearance (K892426) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulation 876.1500, with advisory committee input from the Gastroenterology and Urology (GU) panel.