Cleared Traditional

K945124 - BREAST LESION LOCALIZATION NEEDLE

K945124 is an FDA 510(k) clearance for BREAST LESION LOCALIZATION NEEDLE, manufactured by Promex, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K945124 · Promex, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
34d
Days
Class 1
Risk

K945124 is an FDA 510(k) clearance for the BREAST LESION LOCALIZATION NEEDLE. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Promex, Inc. devices

FDA 510(k) Submission Details - K945124

510(k) Number K945124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1994
Decision Date November 22, 1994
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

GDF Device Classification - Class 1, General Controls

Product Code GDF Guide, Needle, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDF Guide, Needle, Surgical

All 15
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K945124.
SURGICAL INSTRUMENT GUIDE
K950007 · United States Surgical, A Division of Tyco Healthc · Mar 1995
SIMON BREAST LESION LOCALIZATION NEEDLE
K914941 · Manan Medical Products, Inc. · May 1992
PERCUGUIDE LESION MARKING
K920816 · E-Z-Em, Inc. · Apr 1992
ACCUPLACE (TM)
K904172 · Dlp, Inc. · Nov 1990
MICROSURGICAL NEEDLE HOLDERS
K890211 · Kinetic Medical Products · Jan 1989
SURGICAL NEEDLE GUIDE
K890228 · Kinetic Medical Products · Jan 1989