Cleared Traditional

K914941 - SIMON BREAST LESION LOCALIZATION NEEDLE

K914941 is an FDA 510(k) clearance for SIMON BREAST LESION LOCALIZATION NEEDLE, manufactured by Manan Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDF cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K914941 · Manan Medical Products, Inc. · General & Plastic Surgery device
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May 1992
Decision
192d
Days
Class 1
Risk

K914941 is an FDA 510(k) clearance for the SIMON BREAST LESION LOCALIZATION NEEDLE. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on May 14, 1992 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K914941

510(k) Number K914941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date May 14, 1992
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
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 K914941.
SURGICAL INSTRUMENT GUIDE
K950007 · United States Surgical, A Division of Tyco Healthc · Mar 1995
BREAST LESION LOCALIZATION NEEDLE
K945124 · Promex, Inc. · Nov 1994
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