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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Medrad, Inc. devices

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 24
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K874928.
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
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805 · Angiomed U.S., Inc. · Sep 1986
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE
K862481 · CIVCO Medical Instruments Co., Inc. · Jul 1986
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL
K854420 · Meadox Surgimed, Inc. · Nov 1985