Cleared Traditional

K980004 - MANAN GENERAL PURPOSE INTRODUCER NEEDLE

K980004 is the FDA 510(k) clearance for MANAN GENERAL PURPOSE INTRODUCER NEEDLE 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 7-day FDA review.

K980004 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
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Jan 1998
Decision
7d
Days
Class 2
Risk

K980004 is an FDA 510(k) clearance for the MANAN GENERAL PURPOSE INTRODUCER NEEDLE. 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 January 9, 1998 after a review of 7 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 K980004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1998
Decision Date January 09, 1998
Days to Decision 7 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
123d faster than avg
Panel avg: 130d · This submission: 7d
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 K980004.
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K980196 · Medical Device Technologies, Inc. · Feb 1998
MANAN SOFT TISSUE BIOPSY NEEDLES
K980122 · Medical Device Technologies, Inc. · Jan 1998
MANAN(TM) SUPER-CORE BIOPSY NEEDLES
K974814 · Medical Device Technologies, Inc. · Jan 1998
MANAN AUTOMATIC CUTTING NEEDLE
K974446 · Manan Medical Products, Inc. · Jan 1998
MANAN TECHNA-CUT ASPIRATION NEEDLE
K974766 · Medical Device Technologies, Inc. · Jan 1998
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
K974158 · Ortho Development Corp. · Dec 1997