Cleared Traditional

K955397 - MAYFIELD-ACCISS WORKSTATION

K955397 is an FDA 510(k) clearance for MAYFIELD-ACCISS WORKSTATION, manufactured by Nomos Corp.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K955397 · Nomos Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
158d
Days
Class 2
Risk

K955397 is an FDA 510(k) clearance for the MAYFIELD-ACCISS WORKSTATION. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Nomos Corp. (Sewickley, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 158 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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. Standard predicate reliance. 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 Nomos Corp. devices

FDA 510(k) Submission Details - K955397

510(k) Number K955397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date April 30, 1996
Days to Decision 158 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 148d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 267
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K955397.
BRAINLAB HEADPINS
K954789 · Brainlab AG · Aug 1996
COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961858 · Radionics, Inc. · Aug 1996
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
K961639 · Elekta Instrument AB · Jul 1996
CODMAN FIDUCIAL MARKER SYSTEM
K953568 · Codman & Shurtleff, Inc. · Feb 1996
STEALTHSTATION
K954276 · Surgical Navigation Technologies, Inc. · Jan 1996
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K936019 · Nomos Corp. · Mar 1994