Cleared Traditional

K990278 - DAUM NEUROCUT NEUROBIOPSYNEEDLE

K990278 is an FDA 510(k) clearance for DAUM NEUROCUT NEUROBIOPSYNEEDLE, 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 61-day FDA review.

K990278 · Daum Corp. · Gastroenterology & Urology device
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Mar 1999
Decision
61d
Days
Class 2
Risk

K990278 is an FDA 510(k) clearance for the DAUM NEUROCUT NEUROBIOPSYNEEDLE. 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 30, 1999 after a review of 61 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 - K990278

510(k) Number K990278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1999
Decision Date March 30, 1999
Days to Decision 61 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
70d faster than avg
Panel avg: 131d · This submission: 61d
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 306
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K990278.
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K982960 · Medical Device Technologies, Inc. · Sep 1998
LIGHT SABER BONE BIOPSY NEEDLE
K982735 · Minrad, Inc. · Sep 1998