Cleared Traditional

K853770 - CODMAN DISPOSABLE PLASTIC INTRACRANIAL ...

K853770 is the FDA 510(k) clearance for CODMAN DISPOSABLE PLASTIC INTRACRANIAL ... by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K853770 · Codman & Shurtleff, Inc. · Neurology device
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Oct 1986
Decision
392d
Days
Class 2
Risk

K853770 is an FDA 510(k) clearance for the CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on October 6, 1986 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K853770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date October 06, 1986
Days to Decision 392 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 148d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 34
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K853770.
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
CHEEK EPIDURAL SCREW
K802137 · Codman & Shurtleff, Inc. · Oct 1980