Cleared Traditional

K974446 - MANAN AUTOMATIC CUTTING NEEDLE

K974446 is the FDA 510(k) clearance for MANAN AUTOMATIC CUTTING NEEDLE by Manan Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K974446 · Manan Medical Products, Inc. · Gastroenterology & Urology device
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Jan 1998
Decision
44d
Days
Class 2
Risk

K974446 is an FDA 510(k) clearance for the MANAN AUTOMATIC CUTTING NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 44 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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K974446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1997
Decision Date January 08, 1998
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
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 K974446.
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 GENERAL PURPOSE INTRODUCER NEEDLE
K980004 · Medical Device Technologies, 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
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · United States Surgical, A Division of Tyco Healthc · Dec 1997