Cleared Traditional

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (K242128) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242128 · Xaga Surgical · Gastroenterology & Urology device
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Feb 2025
Decision
223d
Days
Class 2
Risk

K242128 is an FDA 510(k) clearance for the Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Fo.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Xaga Surgical (Helsingborg, SE). The FDA issued a Cleared decision on February 27, 2025 after a review of 223 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K242128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2024
Decision Date February 27, 2025
Days to Decision 223 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 130d · This submission: 223d
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 Gastroenterology & Urology 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 K242128.
Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
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ExpressCore Biopsy Device
K243886 · Inrad, Inc. · Apr 2025
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K243945 · SurGenTec, LLC · Apr 2025
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