Cleared Traditional

K844993 - COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720

K844993 is an FDA 510(k) clearance for COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720, manufactured by Omnis Surgical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K844993 · Omnis Surgical, Inc. · Gastroenterology & Urology device
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Feb 1985
Decision
64d
Days
Class 2
Risk

K844993 is an FDA 510(k) clearance for the COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Omnis Surgical, Inc. (Deerfield, US). The FDA issued a Cleared decision on February 28, 1985 after a review of 64 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 Omnis Surgical, Inc. devices

FDA 510(k) Submission Details - K844993

510(k) Number K844993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date February 28, 1985
Days to Decision 64 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
67d faster than avg
Panel avg: 131d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K844993.
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K882549 · Acuson Corp. · Jul 1988
ROTEX SCREW BIOPSY NEEDLE
K854404 · Meadox Surgimed, Inc. · Dec 1985
MEDSURG ULTRASOUND BIOPSY TRAY
K854289 · Medsurg Industries, Inc. · Nov 1985
MONOJECT SOFT TISSUE BIOPSY NEEDLE
K834249 · Sherwood Medical Co. · Mar 1984
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
K840354 · Sherwood Medical Co. · Mar 1984
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
K800416 · A.D.T. Lab Industries · Mar 1980