Cleared Traditional

K961407 - SPEED-CUT

K961407 is an FDA 510(k) clearance for SPEED-CUT, manufactured by Gallini Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K961407 · Gallini Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
224d
Days
Class 2
Risk

K961407 is an FDA 510(k) clearance for the SPEED-CUT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Gallini Intl., Inc. (Cliffside Park, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 224 days - an extended review 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: 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 Intl., Inc. devices

FDA 510(k) Submission Details - K961407

510(k) Number K961407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date November 21, 1996
Days to Decision 224 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 130d · This submission: 224d
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 K961407.
MRI COMPATIBLE BIOPSY NEEDLES
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AUTO SUTURE* ABBI* SYSTEM
K963825 · United States Surgical, A Division of Tyco Healthc · Dec 1996
MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA
K962969 · Medical Device Technologies, Inc. · Dec 1996
SKINNY,FRANSEEN,WESCOTT NEEDLES
K962907 · Baxter Healthcare Corp · Oct 1996
BIOPSY INTRODUCER NEEDLE
K963390 · Baxter Healthcare Corp · Oct 1996
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · C.R. Bard, Inc. · Jul 1996