Cleared Traditional

K973362 - NEEDLE GUIDE/GRID

K973362 is an FDA 510(k) clearance for NEEDLE GUIDE/GRID, manufactured by Protek Medical Products, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K973362 · Protek Medical Products, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
23d
Days
Class 2
Risk

K973362 is an FDA 510(k) clearance for the NEEDLE GUIDE/GRID. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Protek Medical Products, Inc. (Iowa City, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight 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 Protek Medical Products, Inc. devices

FDA 510(k) Submission Details - K973362

510(k) Number K973362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date October 01, 1997
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 272
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K973362.
SONOS 5500 IMAGING SYSTEM
K971116 · Hewlett-Packard Co. · Jan 1998
TRANSDUCER POSITIONER
K973622 · Protek Medical Products, Inc. · Nov 1997
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · Acuson Corp. · Nov 1997
VIEWCATH 3-D CATHETER PULLBACK
K971397 · Quinton, Inc. · Aug 1997
DEVMED STEPPING AND STABILIZING SYSTEM
K972152 · Devmed Corp. · Aug 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY
K972672 · Barzell-Whitmore Maroon Bells, Inc. · Jul 1997