Cleared Traditional

K042290 - VACUUM ASSISTED CORE BIOPSY DEVICE

K042290 is an FDA 510(k) clearance for VACUUM ASSISTED CORE BIOPSY DEVICE, manufactured by Suros Surgical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K042290 · Suros Surgical Systems, Inc. · Gastroenterology & Urology device
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Oct 2004
Decision
43d
Days
Class 2
Risk

K042290 is an FDA 510(k) clearance for the VACUUM ASSISTED CORE BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Suros Surgical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 43 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 Suros Surgical Systems, Inc. devices

FDA 510(k) Submission Details - K042290

510(k) Number K042290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date October 06, 2004
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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 K042290.
ENCOR 7 GAUGE
K051158 · Senorx, Inc. · May 2005
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
K043523 · Medical Device Technologies, Inc. · Feb 2005
MAMMOTOME MR BIOPSY SYSTEM
K042753 · Ethicon Endo-Surgery, Inc. · Nov 2004
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
K042464 · Medical Device Technologies, Inc. · Sep 2004
SENORX BIOPSY DEVICE II
K040842 · Senorx, Inc. · Apr 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · Ethicon Endo-Surgery, Inc. · Feb 2004