Cleared Traditional

K970872 - PAN (CHIBA ASPIRATING NEEDLE)

K970872 is an FDA 510(k) clearance for PAN (CHIBA ASPIRATING NEEDLE), 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 72-day FDA review.

K970872 · Gallini Intl., Inc. · Gastroenterology & Urology device
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May 1997
Decision
72d
Days
Class 2
Risk

K970872 is an FDA 510(k) clearance for the PAN (CHIBA ASPIRATING NEEDLE). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Gallini Intl., Inc. (Glen Allen, US). The FDA issued a Cleared decision on May 21, 1997 after a review of 72 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 Gallini Intl., Inc. devices

FDA 510(k) Submission Details - K970872

510(k) Number K970872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date May 21, 1997
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 131d · This submission: 72d
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 306
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K970872.
MRI COMPATIBLE BIOPSY NEEDLES
K962977 · Manan Medical Products, Inc. · Oct 1997
GALLINI COAXIAL INTRODUCER
K972266 · Gallini U.S., LLC · Jul 1997
TR NEEDLE
K970871 · Gallini Intl., Inc. · May 1997
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
K970565 · Biopsys Medical, Inc. · Mar 1997
SURE CORE BIOPSY KIT
K963813 · Interventional Concepts, Inc. · Mar 1997
TZ
K964777 · Gallini Intl., Inc. · Jan 1997