Cleared Special

K080565 - MODIFICATION TO: SAVI APPLICATOR KIT

K080565 is an FDA 510(k) clearance for MODIFICATION TO: SAVI APPLICATOR KIT, manufactured by Cianna Medical, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Special 510(k) pathway after a 35-day FDA review.

K080565 · Cianna Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
35d
Days
Class 2
Risk

K080565 is an FDA 510(k) clearance for the MODIFICATION TO: SAVI APPLICATOR KIT. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Cianna Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 4, 2008 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Cianna Medical, Inc. devices

FDA 510(k) Submission Details - K080565

510(k) Number K080565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 29, 2008
Decision Date April 04, 2008
Days to Decision 35 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

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