Cleared Traditional

K082159 - CIVASTRING PD-103

K082159 is an FDA 510(k) clearance for CIVASTRING PD-103, manufactured by Civatech Oncology, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K082159 · Civatech Oncology, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
61d
Days
Class 2
Risk

K082159 is an FDA 510(k) clearance for the CIVASTRING PD-103. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Civatech Oncology, Inc. (Mebane, US). The FDA issued a Cleared decision on September 30, 2008 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight 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 - K082159

510(k) Number K082159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2008
Decision Date September 30, 2008
Days to Decision 61 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 107d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 Radiology devices follow this clearance model.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K082159.
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
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POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
K072296 · Theragenics Corp. · Sep 2007
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550 · Cp Medical · Jul 2007
AOS MARKER SEEDS
K062825 · Alpha-Omega Services, Inc. · May 2007
K082159 · CIVASTRING PD-103
Download PDF FDA Summary Civatech Oncology, In…