Cleared Special

K082681 - VACORA VACUUM ASSISTED BIOPSY SYSTEM

K082681 is an FDA 510(k) clearance for VACORA VACUUM ASSISTED BIOPSY SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 30-day FDA review.

K082681 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
30d
Days
Class 2
Risk

K082681 is an FDA 510(k) clearance for the VACORA VACUUM ASSISTED BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on October 15, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082681

510(k) Number K082681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date October 15, 2008
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K082681.
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
K093068 · C.R. Bard, Inc. · Nov 2009
RP CUTTING NEEDLE
K092059 · Riverpoint Medical · Sep 2009
REVOLUTION FULL CORE BIOPSY
K090611 · Inrad · Jun 2009
INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
K081057 · Intact Medical Corporation · Jun 2008
CORAMATE/SPIROTOME SYSTEM
K080095 · Medinvents · Apr 2008
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
K080171 · Sanarus Medical, Inc. · Mar 2008
K082681 · VACORA VACUUM ASSISTED BIOPSY SYSTEM
Download PDF FDA Summary C.R. Bard, Inc.