Cleared Traditional

K981166 - ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214

K981166 is an FDA 510(k) clearance for ACCUCORE CORE BIOPSY NEEDLE CATALOG COD..., 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 83-day FDA review.

K981166 · Inrad · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
83d
Days
Class 2
Risk

K981166 is an FDA 510(k) clearance for the ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Inrad (Kentwood, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 83 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 - K981166

510(k) Number K981166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1998
Decision Date June 22, 1998
Days to Decision 83 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
48d faster than avg
Panel avg: 131d · This submission: 83d
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 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K981166.
SPEED-CUT AUTOMATIC BIOPSY SYSTEM
K981301 · Gallini U.S., LLC · Jul 1998
PERCUTANEOUS BREAST BIOPSY (PBB)
K972328 · Urothealth System, Inc. · Jul 1998
DAUM BONE BIOPSY SET
K981320 · Daum Corp. · Jun 1998
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE
K981477 · Medical Biopsy, Inc. · Jun 1998
SPIGAL NEEDLE
K980676 · Gallini U.S., LLC · May 1998
QUICK-CUT AUTOMATIC BIOPSY SYSTEM
K980479 · Gallini U.S., LLC · May 1998