510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K962097Substantially Equivalent

Ventricular Catheter Set

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

K962097 is the FDA 510(k) clearance record for VENTRICULAR CATHETER SET, a class II device, cleared for Cook, Inc. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K962097.

Clearance record

Decision date
Received
(92 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Cook, Inc. P.O. Box 489, Bloomington IN
510(k) summary
Summary
Third party review
No

Clearances, product code JXG

Trailing 12 months
3 clearances under product code JXG in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261
November 20260