Cleared Special

K032585 - TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032585 · Ron-Tech Medical , Ltd. · Radiology device
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Jan 2004
Decision
141d
Days
Class 2
Risk

K032585 is an FDA 510(k) clearance for the TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM. Classified as Tenaculum, Uterine (product code HDC), Class II - Special Controls.

Submitted by Ron-Tech Medical , Ltd. (Petach-Tikva, IL). The FDA issued a Cleared decision on January 9, 2004 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.4530 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ron-Tech Medical , Ltd. devices

Submission Details

510(k) Number K032585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2003
Decision Date January 09, 2004
Days to Decision 141 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HDC Tenaculum, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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.