Cleared Traditional

K982085 - MEDICAL DEVICE TECHNOLOGIES

K982085 is the FDA 510(k) clearance for MEDICAL DEVICE TECHNOLOGIES by Medical Device Technologies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K982085 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
32d
Days
Class 2
Risk

K982085 is an FDA 510(k) clearance for the MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY IN.... 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 July 17, 1998 after a review of 32 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

Submission Details

510(k) Number K982085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date July 17, 1998
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 173
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K982085.
AUTO SUTURE ABBI SYSTEM
K983296 · United States Surgical, A Division of Tyco Healthc · Jun 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · Medical Device Technologies, Inc. · Sep 1998
PUNCTURENEEDLE
K963794 · Ferguson Medical · Mar 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · Medical Device Technologies, Inc. · Feb 1998
MANAN LIVER BIOPSY KIT
K980452 · Medical Device Technologies, Inc. · Feb 1998