Cleared Traditional

K982960 - MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT

K982960 is an FDA 510(k) clearance for MEICAL DEVICE TECHNOLOGIES, manufactured by Medical Device Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K982960 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Sep 1998
Decision
30d
Days
Class 2
Risk

K982960 is an FDA 510(k) clearance for the MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainsville, US). The FDA issued a Cleared decision on September 23, 1998 after a review of 30 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 Medical Device Technologies, Inc. devices

FDA 510(k) Submission Details - K982960

510(k) Number K982960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1998
Decision Date September 23, 1998
Days to Decision 30 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
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 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K982960.
DAUM NEUROGATE TROCAR
K990782 · Daum GmbH · Apr 1999
DAUM NEUROCUT NEUROBIOPSYNEEDLE
K990278 · Daum Corp. · Mar 1999
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
K983187 · Medsol Corp. · Dec 1998
LIGHT SABER BONE BIOPSY NEEDLE
K982735 · Minrad, Inc. · Sep 1998
PROSTATE BIOPSY NEEDLE
K982401 · Remington Medical, Inc. · Sep 1998
LIGHT SABER CORE TISSUE NEEDLE
K981796 · Minrad, Inc. · Aug 1998