# K960866: LRM Produces Guidewires on an Oem Basis for Manufacturers,Kit Assemblers, and Distributors.

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: Apr 5, 1996 after 32 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.

Source page: https://510kreport.com/device/K960866
Methodology: https://510kreport.com/methodology