Cleared Traditional

K981809 - CAROLINE GUIDE

K981809 is an FDA 510(k) clearance for CAROLINE GUIDE, manufactured by Surgical Solutions, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K981809 · Surgical Solutions, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
85d
Days
Class 2
Risk

K981809 is an FDA 510(k) clearance for the CAROLINE GUIDE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Surgical Solutions, Inc. (Iowa City, US). The FDA issued a Cleared decision on August 14, 1998 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Solutions, Inc. devices

FDA 510(k) Submission Details - K981809

510(k) Number K981809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date August 14, 1998
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
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 333
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K981809.
PHILIPS EASYGUIDE
K980820 · Philips Medical Systems, Inc. · Oct 1998
MAYFIELD ACCISS OPTICAL SYSTEM
K982244 · Ohio Medical Instrument Co., Inc. · Sep 1998
MAGELLAN
K961903 · Biosense, Ltd. · Aug 1998
STEALTHSTATION SYSTEM DIGITIZER CHANGE
K981686 · Surgical Navigation Technologies, Inc. · Aug 1998
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K981684 · Surgical Navigation Technologies, Inc. · Aug 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · Radionics, Inc. · Aug 1998