Cleared Traditional

K981301 - SPEED-CUT AUTOMATIC BIOPSY SYSTEM

K981301 is an FDA 510(k) clearance for SPEED-CUT AUTOMATIC BIOPSY SYSTEM, 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 90-day FDA review.

K981301 · Gallini U.S., LLC · Gastroenterology & Urology device
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Jul 1998
Decision
90d
Days
Class 2
Risk

K981301 is an FDA 510(k) clearance for the SPEED-CUT AUTOMATIC BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Gallini U.S., LLC (Richmond, US). The FDA issued a Cleared decision on July 8, 1998 after a review of 90 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 - K981301

510(k) Number K981301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1998
Decision Date July 08, 1998
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 K981301.
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · Medical Device Technologies, Inc. · Sep 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
K982085 · Medical Device Technologies, Inc. · Jul 1998
PUNCTURENEEDLE
K963794 · Ferguson Medical · Mar 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · Medical Device Technologies, Inc. · Feb 1998
MANAN LIVER BIOPSY KIT
K980452 · Medical Device Technologies, Inc. · Feb 1998