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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 360
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K142791.
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K142477 · Intact Medical Corporation · Dec 2014
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K140991 · Ranfac, Corp. · Sep 2014
K142791 · Spectra Soft Tissue Biopsy Needles
Download PDF FDA Summary Spectra Medical Devic…