Cleared Traditional

K242128 - Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

K242128 is an FDA 510(k) clearance for Forsvall biopsy needle system for prost..., manufactured by Xaga Surgical. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 223-day FDA review.

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.

View all Xaga Surgical devices

FDA 510(k) Submission Details - K242128

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
92d slower than avg
Panel avg: 131d · This submission: 223d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 328
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
K250032 · Bard Peripheral Vascular, Inc. · Jul 2025
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