Cleared Traditional

K874928 - WHOLEY (TM) BIOPSY DEVICE

K874928 is an FDA 510(k) clearance for WHOLEY (TM) BIOPSY DEVICE, manufactured by Medrad, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K874928 · Medrad, Inc. · General & Plastic Surgery device
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Dec 1987
Decision
28d
Days
Class 1
Risk

K874928 is an FDA 510(k) clearance for the WHOLEY (TM) BIOPSY DEVICE. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 28 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.

FDA 510(k) Submission Details - K874928

510(k) Number K874928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date December 30, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
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 47
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K874928.
SPINAL NEEDLE
K882073 · Karlin Technology, Inc. · Jul 1988
BREAST LOCALIZATION NEEDLES
K881730 · Hart Enterprises, Inc. · May 1988
SPINAL NEEDLE
K880812 · T. Korossurgical Instruments Corp. · Mar 1988
RETROBULBAR NEEDLE
K873848 · Healthtek, Inc. · Oct 1987
HAWKINS BREAST LOCALIZATION NEEDLE
K870523 · N-S Medical Products · Mar 1987
GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN
K864193 · Gaw, Inc. · Nov 1986
K874928 · WHOLEY (TM) BIOPSY DEVICE
Download PDF Medrad, Inc.