Cleared Traditional

ExpressCore Biopsy Device (K243886) - FDA 510(k) Clearance

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

K243886 · Inrad, Inc. · General & Plastic Surgery device
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Apr 2025
Decision
132d
Days
Class 2
Risk

K243886 is an FDA 510(k) clearance for the ExpressCore Biopsy Device. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Inrad, Inc. (Kentwood, US). The FDA issued a Cleared decision on April 29, 2025 after a review of 132 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 Inrad, Inc. devices

Submission Details

510(k) Number K243886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2024
Decision Date April 29, 2025
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
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 Peers - KNW Instrument, Biopsy

All 105
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K243886.
Disposable Biopsy Needle
K244018 · Zhejiang Curaway Medical Technology Co., Ltd. · Jul 2025
Disposable Biopsy Needle
K243296 · Carbon (Shenzhen) Medical Device Co., Ltd. · Jul 2025
Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
K250032 · Bard Peripheral Vascular, Inc. · Jul 2025
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K243945 · SurGenTec, LLC · Apr 2025
Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
K242128 · Xaga Surgical · Feb 2025
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
K241793 · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 2025