Cleared Traditional

K140991 - RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE

K140991 is an FDA 510(k) clearance for RANFAC ASPIRATION NEEDLE WITH ADJUSTABL..., manufactured by Ranfac, Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K140991 · Ranfac, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
147d
Days
Class 2
Risk

K140991 is an FDA 510(k) clearance for the RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on September 11, 2014 after a review of 147 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K140991

510(k) Number K140991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2014
Decision Date September 11, 2014
Days to Decision 147 days
Submission Type Traditional
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
16d slower than avg
Panel avg: 131d · This submission: 147d
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 362
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K140991.
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K142477 · Intact Medical Corporation · Dec 2014
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · Care Fusion · Sep 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014
PRESTO BREAST BIOPSY DEVICE
K133702 · Sontina Medical, LLC · Feb 2014
K140991 · RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
Download PDF FDA Summary Ranfac, Corp.