510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970994Substantially Equivalent

Core and Coil Assembly Guidewire

Lake Region Mfg., Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970994 is the FDA 510(k) clearance record for CORE AND COIL ASSEMBLY GUIDEWIRE, a class I device, cleared for Lake Region Mfg., Inc. on under FDA product code EZB (Stylet For Catheter, Gastro-Urology). FDA records list 42 510(k) clearances for Lake Region Mfg., Inc., from to . As of , FDA records show no recalls naming K970994.

Clearance record

Decision date
Received
(6 days to decision)
Product code
EZB Stylet For Catheter, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Lake Region Mfg., Inc. 340 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code EZB

Trailing 12 months

FDA records hold no clearances under product code EZB in the trailing twelve months.

FDA records show no clearances under product code EZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EZB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260