Cleared Traditional

K844993 - COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720

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

K844993 · Omnis Surgical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
66d faster than avg
Panel avg: 130d · This submission: 64d
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 K844993.
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