Cleared Traditional

K083157 - HS AMICA

K083157 is an FDA 510(k) clearance for HS AMICA, manufactured by H.S Hospital Service S.P.A. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K083157 · H.S Hospital Service S.P.A · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
340d
Days
Class 2
Risk

K083157 is an FDA 510(k) clearance for the HS AMICA. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by H.S Hospital Service S.P.A (Boca Raton, US). The FDA issued a Cleared decision on September 29, 2009 after a review of 340 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 878.4400 - 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.

View all H.S Hospital Service S.P.A devices

FDA 510(k) Submission Details - K083157

510(k) Number K083157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2008
Decision Date September 29, 2009
Days to Decision 340 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
225d slower than avg
Panel avg: 115d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEY Device Classification - Class 2, Special Controls

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - NEY System, Ablation, Microwave And Accessories

All 40
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K083157.
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
K162449 · AngioDynamics, Inc. · May 2017
Emprint Ablation System
K163105 · Covidien, LLC · Dec 2016
EMPRINT ABLATION SYSTEM
K133821 · Covidien, LLC · Apr 2014
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · Guidant Corp. · Jul 2006