Cleared Traditional

K973152 - GALLINI ABS DEVICE

K973152 is an FDA 510(k) clearance for GALLINI ABS DEVICE, manufactured by Gallini U.S., LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K973152 · Gallini U.S., LLC · Gastroenterology & Urology device
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Jan 1998
Decision
140d
Days
Class 2
Risk

K973152 is an FDA 510(k) clearance for the GALLINI ABS DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Gallini U.S., LLC (Glen Allen, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gallini U.S., LLC devices

FDA 510(k) Submission Details - K973152

510(k) Number K973152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date January 09, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 130d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K973152.
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
K980211 · Manan Medical Products, Inc. · Feb 1998
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K980196 · Medical Device Technologies, Inc. · Feb 1998
MANAN SOFT TISSUE BIOPSY NEEDLES
K980122 · Medical Device Technologies, Inc. · Jan 1998
MANAN(TM) SUPER-CORE BIOPSY NEEDLES
K974814 · Medical Device Technologies, Inc. · Jan 1998
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K980004 · Medical Device Technologies, Inc. · Jan 1998
MANAN AUTOMATIC CUTTING NEEDLE
K974446 · Manan Medical Products, Inc. · Jan 1998