Cleared Traditional

K150112 - HS AMICA DEVICES FAMILY

K150112 is an FDA 510(k) clearance for HS AMICA DEVICES FAMILY, manufactured by H.S Hospital Service S.P.A. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K150112 · H.S Hospital Service S.P.A · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
233d
Days
Class 2
Risk

K150112 is an FDA 510(k) clearance for the HS AMICA DEVICES FAMILY. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by H.S Hospital Service S.P.A (Aprilia (Lt), IT). The FDA issued a Cleared decision on September 10, 2015 after a review of 233 days - an extended review cycle.

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

FDA 510(k) Submission Details - K150112

510(k) Number K150112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date September 10, 2015
Days to Decision 233 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 115d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Consultant

Isemed S.R.L.
Maurizio Pantaleoni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 2001
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K150112.
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
K134036 · Loktal Medical Electronics Ind. Com. Ltda- Epp · Oct 2015
Stretta Catheter
K152317 · Mederi Therapeutics, Inc. · Sep 2015
New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
K152031 · New Deantronics Taiwan , Ltd. · Sep 2015
Sutter Bipolar Forceps-Calvian
K150959 · Sutter Medizintechnik GmbH · Sep 2015
Valleylab FT10 Electrosurgical Platform
K151649 · Covidien · Sep 2015
LigaSure Curved, Small Jaw, Open Sealer/Divider
K152286 · Covidien · Sep 2015