510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K853770Substantially Equivalent

Codman Disposable Plastic Intracranial Press/kit

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

K853770 is the FDA 510(k) clearance record for CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT, a class II device, cleared for Codman & Shurtleff, Inc. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 163 510(k) clearances for Cerenovus, Inc., from to . As of , FDA records show 5 recalls naming K853770.

Clearance record

Decision date
Received
(392 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Codman & Shurtleff, Inc. 41 Pacella Park Dr., Randolph MA
Third party review
No

Clearances, product code GWM

Trailing 12 months
1 clearance under product code GWM in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260