Cleared Traditional

K875236 - TRANS/P NEEDLE GUIDE

K875236 is the FDA 510(k) clearance for TRANS/P NEEDLE GUIDE by CIVCO Medical Instruments Co., Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K875236 · CIVCO Medical Instruments Co., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
115d
Days
Class 2
Risk

K875236 is an FDA 510(k) clearance for the TRANS/P NEEDLE GUIDE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on April 15, 1988 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all CIVCO Medical Instruments Co., Inc. devices

Submission Details

510(k) Number K875236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date April 15, 1988
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 409
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K875236.
7.5 MHZ ENDORECTAL PROBE
K881028 · Philips Ultrasound, Inc. · Apr 1988
DIASONICS QT ENDORECTAL 7.5 MHZ PROBE
K880714 · Diasonics, Inc. · Apr 1988
THE ESI-2000 ULTRASOUND UNIT
K874683 · Elscint, Inc. · Apr 1988
TRANSRECTAL PROBE BD65S-TR
K880219 · Elscint, Inc. · Mar 1988
SDR 3500 (PHILIPS PLATINUM +)
K873937 · Philips Ultrasound, Inc. · Mar 1988
NIDEK UP-2000
K880065 · Nidek, Inc. · Mar 1988