Cleared Traditional

K120804 - CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM

K120804 is an FDA 510(k) clearance for CIANNA MEDICAL TISSUE MARKER AND DELIVE..., manufactured by Cianna Medical. The device is a Class 2 General & Plastic Surgery device with product code PBY cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K120804 · Cianna Medical · General & Plastic Surgery device
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Feb 2013
Decision
325d
Days
Class 2
Risk

K120804 is an FDA 510(k) clearance for the CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM. Classified as Temporary Tissue Marker (product code PBY), Class II - Special Controls.

Submitted by Cianna Medical (Aliso Viejo, US). The FDA issued a Cleared decision on February 4, 2013 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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. Elevated predicate reliance profile. 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.

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FDA 510(k) Submission Details - K120804

510(k) Number K120804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2012
Decision Date February 04, 2013
Days to Decision 325 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
210d slower than avg
Panel avg: 115d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBY Device Classification - Class 2, Special Controls

Product Code PBY Temporary Tissue Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
Definition To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue.
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 - PBY Temporary Tissue Marker

Devices cleared under the same product code (PBY) and FDA review panel - the closest regulatory comparables to K120804.
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