510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041544Substantially Equivalent

Cook Sidearm Core Tissue Biopsy Device

Urological, Inc., Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041544 is the FDA 510(k) clearance record for COOK SIDEARM CORE TISSUE BIOPSY DEVICE, a class II device, cleared for Urological, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list one 510(k) clearance for Urological, Inc. As of , FDA records show no recalls naming K041544.

Clearance record

Decision date
Received
(43 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary PDF
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