Cleared Traditional

K034021 - VACUUM ASSISTED CORE BIOPSY DEVICE

K034021 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 259-day FDA review.

K034021 · Suros Surgical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
259d
Days
Class 2
Risk

K034021 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 September 8, 2004 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Suros Surgical Systems, Inc. devices

FDA 510(k) Submission Details - K034021

510(k) Number K034021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2003
Decision Date September 08, 2004
Days to Decision 259 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
129d slower than avg
Panel avg: 130d · This submission: 259d
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 K034021.
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
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003