Cleared Traditional

K982401 - PROSTATE BIOPSY NEEDLE

K982401 is an FDA 510(k) clearance for PROSTATE BIOPSY NEEDLE, manufactured by Remington Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K982401 · Remington Medical, Inc. · Gastroenterology & Urology device
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Sep 1998
Decision
60d
Days
Class 2
Risk

K982401 is an FDA 510(k) clearance for the PROSTATE BIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 8, 1998 after a review of 60 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 Remington Medical, Inc. devices

FDA 510(k) Submission Details - K982401

510(k) Number K982401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1998
Decision Date September 08, 1998
Days to Decision 60 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
71d faster than avg
Panel avg: 131d · This submission: 60d
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 325
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K982401.
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
K983187 · Medsol Corp. · Dec 1998
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · Medical Device Technologies, Inc. · Sep 1998
LIGHT SABER BONE BIOPSY NEEDLE
K982735 · Minrad, Inc. · Sep 1998
LIGHT SABER CORE TISSUE NEEDLE
K981796 · Minrad, Inc. · Aug 1998
C0-AXIAL INTRODUCER NEEDLE
K981721 · Inrad · Jul 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
K982085 · Medical Device Technologies, Inc. · Jul 1998