Cleared Traditional

K840354 - MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE

K840354 is an FDA 510(k) clearance for MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE, manufactured by Sherwood Medical Co.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K840354 · Sherwood Medical Co. · Gastroenterology & Urology device
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Mar 1984
Decision
46d
Days
Class 2
Risk

K840354 is an FDA 510(k) clearance for the MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 46 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K840354

510(k) Number K840354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date March 12, 1984
Days to Decision 46 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 131d · This submission: 46d
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 85
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K840354.
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
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)
K800416 · A.D.T. Lab Industries · Mar 1980
ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL
K800419 · A.D.T. Lab Industries · Mar 1980
ADT PERCUTANEOUS NON-DISP. NEEDLE
K800420 · A.D.T. Lab Industries · Mar 1980