Cleared Traditional

K031344 - RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE

K031344 is an FDA 510(k) clearance for RANFAC GOLDENBERG SNARECOIL SOFT TISSUE..., 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 24-day FDA review.

K031344 · Ranfac, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
24d
Days
Class 2
Risk

K031344 is an FDA 510(k) clearance for the RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ranfac, Corp. (Foster, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 24 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.

FDA 510(k) Submission Details - K031344

510(k) Number K031344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2003
Decision Date May 23, 2003
Days to Decision 24 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
107d faster than avg
Panel avg: 131d · This submission: 24d
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 K031344.
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
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K032506 · Sanarus Medical, Inc. · Oct 2003
EXCISOR BIOPTOME, MODEL 01-0004
K032847 · Acueity, Inc. · Sep 2003
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
K030443 · Nastech Pharmaceutical Company, Inc. · May 2003
VACUFLASH BIOPSY SYSTEM
K024089 · Bip USA, Inc. · Mar 2003
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
K023923 · Senorx, Inc. · Dec 2002
K031344 · RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
Download PDF FDA Summary Ranfac, Corp.