Cleared Traditional

TRAP EASY (K242029) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242029 · H.S Hospital Service S.P.A · General & Plastic Surgery device
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Oct 2024
Decision
90d
Days
Class 2
Risk

K242029 is an FDA 510(k) clearance for the TRAP EASY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by H.S Hospital Service S.P.A (Rome, IT). The FDA issued a Cleared decision on October 9, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - 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

Submission Details

510(k) Number K242029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2024
Decision Date October 09, 2024
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - KNW Instrument, Biopsy

All 105
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K242029.
Bone Marrow Biopsy Needle
K242322 · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 2025
Triopsy Actuator (TMSDGB)
K242228 · Triopsy Medical, Inc. · Jan 2025
Mammotome AutoCore™ Single Insertion Core Biopsy System
K243095 · Devicor Medical Products, Inc. · Oct 2024
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K240664 · SurGenTec, LLC · Aug 2024
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
K233294 · Itp Innovative Tomography Products GmbH · Jun 2024
M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
K233031 · Canyon Medical, Inc. · Jan 2024