Cleared Traditional

K800416 - ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA)

K800416 is an FDA 510(k) clearance for ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA), manufactured by A.D.T. Lab Industries. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K800416 · A.D.T. Lab Industries · Gastroenterology & Urology device
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Mar 1980
Decision
28d
Days
Class 2
Risk

K800416 is an FDA 510(k) clearance for the ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA). Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by A.D.T. Lab Industries (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 28 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 A.D.T. Lab Industries devices

FDA 510(k) Submission Details - K800416

510(k) Number K800416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date March 25, 1980
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
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 92
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K800416.
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 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