Cleared Traditional

K972496 - PENCIL-GRIP FNA SYRINGE HOLDER AND EFFO...

K972496 is an FDA 510(k) clearance for PENCIL-GRIP FNA SYRINGE HOLDER AND EFFO..., manufactured by Tao & Tao Technologyt, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K972496 · Tao & Tao Technologyt, Inc. · Gastroenterology & Urology device
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Dec 1997
Decision
159d
Days
Class 2
Risk

K972496 is an FDA 510(k) clearance for the PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Tao & Tao Technologyt, Inc. (Carmel, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 159 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 Tao & Tao Technologyt, Inc. devices

FDA 510(k) Submission Details - K972496

510(k) Number K972496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date December 09, 1997
Days to Decision 159 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
29d slower than avg
Panel avg: 130d · This submission: 159d
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 K972496.
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ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
K974158 · Ortho Development Corp. · Dec 1997
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · United States Surgical, A Division of Tyco Healthc · Dec 1997
QUICK-CARE BIOPSY NEEDLE
K973565 · Cook, Inc. · Nov 1997