Cleared Traditional

K142791 - Spectra Soft Tissue Biopsy Needles

K142791 is an FDA 510(k) clearance for Spectra Soft Tissue Biopsy Needles, manufactured by Spectra Medical Devices. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K142791 · Spectra Medical Devices · General & Plastic Surgery device
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Jan 2015
Decision
117d
Days
Class 2
Risk

K142791 is an FDA 510(k) clearance for the Spectra Soft Tissue Biopsy Needles. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Spectra Medical Devices (Wilmington, US). The FDA issued a Cleared decision on January 21, 2015 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectra Medical Devices devices

FDA 510(k) Submission Details - K142791

510(k) Number K142791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2014
Decision Date January 21, 2015
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 206
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K142791.
Imbibe Needle
K153306 · Orthovita, Inc. · Dec 2015
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · Care Fusion · Sep 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
K133948 · Bard Peripheral Vascular, Inc. · Feb 2014