Cleared Traditional

K854289 - MEDSURG ULTRASOUND BIOPSY TRAY

K854289 is the FDA 510(k) clearance for MEDSURG ULTRASOUND BIOPSY TRAY by Medsurg Industries, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K854289 · Medsurg Industries, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
32d
Days
Class 2
Risk

K854289 is an FDA 510(k) clearance for the MEDSURG ULTRASOUND BIOPSY TRAY. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on November 26, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Medsurg Industries, Inc. devices

Submission Details

510(k) Number K854289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date November 26, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCG Biopsy Needle

All 43
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K854289.
WILSON-COOK GI ASPIRATION NEEDLE
K934356 · Wilson-Cook Medical, Inc. · Jan 1994
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991
BIOPSY NEEDLE GUIDE ATTACHMENT
K890327 · Elscint, Inc. · Mar 1989
MONOJECT SOFT TISSUE BIOPSY NEEDLE
K834249 · Sherwood Medical Co. · Mar 1984
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
K840354 · Sherwood Medical Co. · Mar 1984