Cleared Traditional

K232072 - AMICA-GEN AGN-H-1.3

K232072 is an FDA 510(k) clearance for AMICA-GEN AGN-H-1.3, 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 212-day FDA review.

K232072 · H.S Hospital Service S.P.A · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
212d
Days
Class 2
Risk

K232072 is an FDA 510(k) clearance for the AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G. 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 February 9, 2024 after a review of 212 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 - K232072

510(k) Number K232072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2023
Decision Date February 09, 2024
Days to Decision 212 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
97d slower than avg
Panel avg: 115d · This submission: 212d
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.
Guido Bonapace

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 1257
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K232072.
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)
K233879 · Maquet Cardiovascular, LLC · Feb 2024
Oligio X
K240313 · Wontech Co., Ltd. · Feb 2024
Disposable Grounding Pad
K231985 · Shenzhen Mecun Medical Supply Co., Ltd. · Feb 2024
VIVA combo RF System (VIVA combo RF System)
K234140 · Starmed Co., Ltd. · Jan 2024
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
K233425 · Sutter Medizintechnik GmbH · Jan 2024
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
K231405 · Jiangsu Rong FU Kang Medical Instruments Co., Ltd. · Jan 2024