Hydrophilic Coated Guidewire

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

510(k) Number

K981667 ↗

FDA Product Code

KNY

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Cardiovascular Spring Guides Open recall

  Class II

  FDA 510(k) K770977 Active Cleared 14 Jun 1977

• Lrm Produces Guidewires on an Oem Basis for Manufacturers, Kit Assemblers, and Distributors.

  Class II

  FDA 510(k) K960866 Active Cleared 5 Apr 1996

• Lake Region Variable Stiffness Guidewire (Vsgw)

  Class II

  FDA 510(k) K871882 Active Cleared 15 Sep 1987

• Fasiculated Nail

  Class II

  FDA 510(k) K861365 Active Cleared 6 May 1986

• Torque Handle Device for Guidewire

  Class II

  FDA 510(k) K905639 Active Cleared 20 Feb 1991

• Steerable Guidewire

  Class II

  FDA 510(k) K022813 Active Cleared 14 Feb 2003

See all devices from Lake Region Mfg., Inc. →

• What is the hydrophilic coated guidewire used for?

  The hydrophilic coated guidewire is designed for use in catheter-based procedures to reduce friction and facilitate navigation through vascular or luminal pathways, specifically in gastroenterology and urology applications as indicated in its FDA 510(k) clearance.

• Is the hydrophilic coated guidewire sterile and single-use?

  Yes, the device is supplied sterile and intended for single-use only, as stated in the device description, to ensure patient safety and prevent cross-contamination during procedures.

• What regulatory pathway was used to clear the hydrophilic coated guidewire?

  The hydrophilic coated guidewire was cleared via the traditional 510(k) pathway under FDA clearance number K981667, based on a determination of substantial equivalence to a legally marketed predicate device.

• What is the FDA classification and product code for the hydrophilic coated guidewire?

  The device is classified as a Class II medical device under FDA regulation number 876.5130, with product code KNY, which identifies it as an accessory catheter for gastroenterology and urology use.