Cleared Traditional

K181007 - Cianna Medical SAVI Scout Reflector and...

K181007 is an FDA 510(k) clearance for Cianna Medical SAVI Scout Reflector and..., manufactured by Cianna Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K181007 · Cianna Medical, Inc. · General & Plastic Surgery device
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Aug 2018
Decision
107d
Days
Class 2
Risk

K181007 is an FDA 510(k) clearance for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Cianna Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on August 2, 2018 after a review of 107 days - within the typical 510(k) review window.

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. 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.

View all Cianna Medical, Inc. devices

FDA 510(k) Submission Details - K181007

510(k) Number K181007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date August 02, 2018
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - NEU Marker, Radiographic, Implantable

All 64
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