Cleared Traditional

K974575 - DAUM ASPIRATIONBIOPSY NEEDLE

K974575 is an FDA 510(k) clearance for DAUM ASPIRATIONBIOPSY NEEDLE, manufactured by Daum Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974575 · Daum Corp. · Gastroenterology & Urology device
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Mar 1998
Decision
88d
Days
Class 2
Risk

K974575 is an FDA 510(k) clearance for the DAUM ASPIRATIONBIOPSY NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Daum Corp. (Crofton, US). The FDA issued a Cleared decision on March 6, 1998 after a review of 88 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 Daum Corp. devices

FDA 510(k) Submission Details - K974575

510(k) Number K974575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date March 06, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
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 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K974575.
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PUNCTURENEEDLE
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K980211 · Manan Medical Products, Inc. · Feb 1998