510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K892215Substantially Equivalent

Uni-Shunt(tm) with Elliptical Reservoir Kit

Cerenovus, Inc., Randolph MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892215 is the FDA 510(k) clearance record for UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show no recalls naming K892215.

Clearance record

Decision date
Received
(140 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
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
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