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Ostavi Hydrophilic Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K124052

by Lake Region Medical

Identifiers

510(k) Number
K124052 FDA 510(k)
FDA Product Code
OCY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ostavi Hydrophilic Guidewire is an Endoscopic Guidewire designed for use in gastroenterology and urology procedures. It features a hydrophilic coating over a radiopaque polymer jacket, enabling smooth advancement through tortuous anatomy and facilitating selective cannulation of ducts. The device is engineered with a metallic core (Nitinol) for structural support and flexibility, allowing precise navigation during endoscopic interventions.

The guidewire is supplied in lengths of 260 cm and available in diameters of 0.018" or 0.025", with options for straight or pre-shaped distal tips and varying tip flexibilities based on grind configuration. It is intended for single-use applications and is classified as a Class II device under FDA regulations. The device received FDA 510(k) clearance (K124052) as substantially equivalent to predicate products, adhering to regulatory standards for endoscopic and biliary procedures.

Frequently asked questions

What medical specialties is the Ostavi Hydrophilic Guidewire primarily used in, and how does its design support those applications?

The Ostavi Hydrophilic Guidewire is designed for use in gastroenterology and urology procedures, as indicated by its regulatory filings. Its hydrophilic coating and radiopaque polymer jacket allow for smooth navigation through complex, tortuous anatomy, which is critical in both specialties. The Nitinol metallic core provides structural support and flexibility, enabling precise control during endoscopic interventions like biliary cannulation or ureteral access. This combination of features makes it suitable for selective cannulation tasks in these fields.

Is the Ostavi Hydrophilic Guidewire reusable, and if not, what are the implications for clinical workflow?

The Ostavi Hydrophilic Guidewire is intended for single-use only, as explicitly stated in its description. This design choice ensures patient safety by eliminating cross-contamination risks and reduces the need for reprocessing, streamlining clinical workflows. Clinicians should follow manufacturer guidelines for proper disposal after a single procedure to maintain sterility and compliance.

What lengths and diameters are available for the Ostavi Hydrophilic Guidewire, and how might these variations impact procedure selection?

The guidewire is supplied in a single length of 260 cm, which provides ample reach for most endoscopic and urological procedures. It is available in two diameters: 0.018” and 0.025”, catering to different catheter or sheath sizes used in the procedure. The choice of diameter may depend on the specific instrumentation being used, with the smaller diameter offering more flexibility for delicate maneuvers and the larger diameter providing added support for stiffer guidewire applications.

How should the Ostavi Hydrophilic Guidewire be stored to ensure optimal performance and sterility?

Since the Ostavi Hydrophilic Guidewire is single-use and sterile, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed to protect the hydrophilic coating and radiopaque properties, so it should remain unopened until immediately before use. Proper storage ensures the guidewire retains its lubricity and structural integrity for the intended procedure.

What regulatory pathway was followed for FDA clearance of the Ostavi Hydrophilic Guidewire, and what does this mean for clinicians?

The Ostavi Hydrophilic Guidewire received FDA 510(k) clearance (K124052) under the Traditional 510(k) Review pathway, demonstrating it is substantially equivalent to predicate devices already on the market. This means it meets FDA standards for safety and effectiveness as an Endoscopic Guidewire for gastroenterology and urology procedures. Clinicians can rely on its regulatory approval as evidence of compliance with U.S. medical device regulations, though they should always refer to the manufacturer’s instructions for use for procedure-specific guidance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ostavi Hydrophilic Guidewire - Lake Region Medical | FDA Evidence Review, OSTAVI HYDROPHILIC GUIDEWIRE by LAKE REGION MEDICAL | FDA 510 (k) Summary, OSTAVI HYDROPHILIC GUIDEWIRE (K124052) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lake Region Medical

Sources (1)

  • FDA 510(k) K124052 24 fields · synced Oct 6, 2026