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
K921200Substantially Equivalent

Guidewire

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

K921200 is the FDA 510(k) clearance record for GUIDEWIRE, a class II device, cleared for Lake Region Mfg., Inc. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 42 510(k) clearances for Lake Region Mfg., Inc., from to . As of , FDA records show no recalls naming K921200.

Clearance record

Decision date
Received
(176 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
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 KNY

Trailing 12 months
1 clearance under product code KNY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260