Cleared Traditional

Mammotome AutoCore™ Single Insertion Core Biopsy System (K243095) - FDA 510(k) Clearance

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

K243095 · Devicor Medical Products, Inc. · General & Plastic Surgery device
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Oct 2024
Decision
29d
Days
Class 2
Risk

K243095 is an FDA 510(k) clearance for the Mammotome AutoCore™ Single Insertion Core Biopsy System. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 29, 2024 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devicor Medical Products, Inc. devices

Submission Details

510(k) Number K243095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date October 29, 2024
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 K243095.
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
K241793 · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 2025
Bone Marrow Biopsy Needle
K242322 · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 2025
Triopsy Actuator (TMSDGB)
K242228 · Triopsy Medical, Inc. · Jan 2025
TRAP EASY
K242029 · H.S Hospital Service S.P.A · 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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.