510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K863385Substantially Equivalent

(Roth)spiral Rotating Prostatic Biopsy Needle

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863385 is the FDA 510(k) clearance record for (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE, a class I device, cleared for Cook Urological, Inc. on under FDA product code KNN (Components, Wheelchair). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K863385.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KNN Components, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
Third party review
No

Clearances, product code KNN

Trailing 12 months

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

FDA records show no clearances under product code KNN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNN, 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