Cleared Traditional

K031344 - RANFAC GOLDENBERG SNARECOIL SOFT TISSUE...

K031344 is the FDA 510(k) clearance for RANFAC GOLDENBERG SNARECOIL SOFT TISSUE... by Ranfac, Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K031344 · Ranfac, Corp. · Gastroenterology & Urology device
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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.

View all Ranfac, Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 111
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K031344.
MAMMOTOME EX HAND HELD SYSTEM
K033700 · Ethicon Endo-Surgery, Inc. · Feb 2004
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · Ethicon Endo-Surgery, Inc. · Jan 2001
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
K992813 · Ethicon Endo-Surgery, Inc. · Nov 1999
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
K991980 · Ethicon Endo-Surgery, Inc. · Aug 1999