Cleared Traditional

K242029 - TRAP EASY

K242029 is an FDA 510(k) clearance for TRAP EASY, manufactured by H.S Hospital Service S.P.A. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K242029

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.

KNW Device Classification - Class 2, Special Controls

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 182
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