Cleared Traditional

K093399 - PRECISECORE 10 MM BIOPSY DEVICE- 14GA X...

K093399 is an FDA 510(k) clearance for PRECISECORE 10 MM BIOPSY DEVICE- 14GA X..., manufactured by Inrad. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K093399 · Inrad · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Nov 2009
Decision
17d
Days
Class 2
Risk

K093399 is an FDA 510(k) clearance for the PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Inrad (Kentwood, US). The FDA issued a Cleared decision on November 19, 2009 after a review of 17 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 Inrad devices

FDA 510(k) Submission Details - K093399

510(k) Number K093399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2009
Decision Date November 19, 2009
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
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 K093399.
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K082681 · C.R. Bard, Inc. · Oct 2008