Cleared Special

K013964 - MODIFICATION TO ACCU-SPACE PLAIN GUT AB...

K013964 is the FDA 510(k) clearance for MODIFICATION TO ACCU-SPACE PLAIN GUT AB... by Cp Medical. It is a Class 2 Radiology device (product code KXK) cleared through the Special 510(k) pathway after a 52-day FDA review.

K013964 · Cp Medical · Radiology device
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Jan 2002
Decision
52d
Days
Class 2
Risk

K013964 is an FDA 510(k) clearance for the MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Cp Medical (Portland, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 52 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cp Medical devices

Submission Details

510(k) Number K013964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date January 24, 2002
Days to Decision 52 days
Submission Type Special
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
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 29
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K013964.
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · Varian Medical Systems · Mar 2003
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · Cp Medical · Jul 2002
CP-SLEEVE
K013975 · Cp Medical · Feb 2002
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990