Cleared Traditional

K881730 - BREAST LOCALIZATION NEEDLES

K881730 is an FDA 510(k) clearance for BREAST LOCALIZATION NEEDLES, manufactured by Hart Enterprises, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K881730 · Hart Enterprises, Inc. · General & Plastic Surgery device
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May 1988
Decision
21d
Days
Class 1
Risk

K881730 is an FDA 510(k) clearance for the BREAST LOCALIZATION NEEDLES. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Hart Enterprises, Inc. (Wyoming, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 21 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 Hart Enterprises, Inc. devices

FDA 510(k) Submission Details - K881730

510(k) Number K881730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date May 13, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

Product Code GDM Needle, Aspiration And Injection, Reusable
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 - GDM Needle, Aspiration And Injection, Reusable

All 25
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K881730.
STORZ UNIV IRRIGAT/ASPIRA & PHACOEMULSIFCATION PAC
K882240 · Storz Instrument Co. · Jul 1988
E-Z-EM(R) LUFKIN BIOPSY NEEDLES
K882601 · E-Z-Em, Inc. · Jul 1988
SPINAL NEEDLE
K882073 · Karlin Technology, Inc. · Jul 1988
SPINAL NEEDLE
K880812 · T. Korossurgical Instruments Corp. · Mar 1988
WHOLEY (TM) BIOPSY DEVICE
K874928 · Medrad, Inc. · Dec 1987
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805 · Angiomed U.S., Inc. · Sep 1986