510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983867Substantially Equivalent

Fuji Catheter, Model Cth001

Windy Hill Technology, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983867 is the FDA 510(k) clearance record for FUJI CATHETER, MODEL CTH001, a class II device, cleared for Windy Hill Technology, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 2 510(k) clearances for Windy Hill Technology, Inc., from to . As of , FDA records show no recalls naming K983867.

Clearance record

Decision date
Received
(219 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Windy Hill Technology, Inc. 1010 Hamilton Ct., Menlo Park CA
510(k) summary
Summary
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260