Cleared Traditional

K140137 - SAFETY BIOPSY NEEDLE SYSTEM

K140137 is an FDA 510(k) clearance for SAFETY BIOPSY NEEDLE SYSTEM, manufactured by Pfm Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K140137 · Pfm Medical, Inc. · Gastroenterology & Urology device
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Mar 2014
Decision
62d
Days
Class 2
Risk

K140137 is an FDA 510(k) clearance for the SAFETY BIOPSY NEEDLE SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 25, 2014 after a review of 62 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 Pfm Medical, Inc. devices

FDA 510(k) Submission Details - K140137

510(k) Number K140137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date March 25, 2014
Days to Decision 62 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
69d faster than avg
Panel avg: 131d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FCG Device Classification - Class 2, Special Controls

Product Code FCG Biopsy Needle
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
MARK JOB

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 - FCG Biopsy Needle

All 85
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K140137.
HS NOTA
K131925 · H.S. Hospital Services S.P.A. · Oct 2014
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K141894 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · Oct 2014
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K133763 · Medi-Globe Corporation · May 2014
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
K133008 · Beacon Endoscopic · Nov 2013
TISSUE SAMPLING NEEDLE
K103694 · United States Endoscopy Group, Inc. · Jul 2011
BNX FINE NEEDLE ASPIRATION SYSTEM
K103668 · Boston Endoscopic Engineering · Dec 2010

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.