Cleared Traditional

K093512 - ENCOR BREAST BIOPSY SYSTEM

K093512 is an FDA 510(k) clearance for ENCOR BREAST BIOPSY SYSTEM, manufactured by Senorx, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K093512 · Senorx, Inc. · Gastroenterology & Urology device
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Nov 2009
Decision
7d
Days
Class 2
Risk

K093512 is an FDA 510(k) clearance for the ENCOR BREAST BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Irvine, US). The FDA issued a Cleared decision on November 20, 2009 after a review of 7 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 Senorx, Inc. devices

FDA 510(k) Submission Details - K093512

510(k) Number K093512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date November 20, 2009
Days to Decision 7 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 131d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNW Instrument, Biopsy

All 290
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K093512.
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
K103359 · C.R. Bard, Inc. · Dec 2010
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
K101832 · Medical Device Technologies, Inc. · Aug 2010
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
K093899 · Ethicon Endo-Surgery, LLC · Apr 2010
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
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · C.R. Bard, Inc. · Oct 2008

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.