Cleared Traditional

K233294 - Automatic Biopsy Needle BAM

K233294 is an FDA 510(k) clearance for Automatic Biopsy Needle BAM, manufactured by Itp Innovative Tomography Products GmbH. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K233294 · Itp Innovative Tomography Products GmbH · General & Plastic Surgery device
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Jun 2024
Decision
263d
Days
Class 2
Risk

K233294 is an FDA 510(k) clearance for the Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Itp Innovative Tomography Products GmbH (Bochum, DE). The FDA issued a Cleared decision on June 18, 2024 after a review of 263 days - an extended review 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: 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 Itp Innovative Tomography Products GmbH devices

FDA 510(k) Submission Details - K233294

510(k) Number K233294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date June 18, 2024
Days to Decision 263 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
148d slower than avg
Panel avg: 115d · This submission: 263d
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 Peers - KNW Instrument, Biopsy

All 183
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K233294.
Mammotome AutoCore™ Single Insertion Core Biopsy System
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M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
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SUREcore Prime Biopsy Instrument
K230646 · Uro-1 Medical, Inc. · Nov 2023
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K233220 · Senorx, Inc. · Oct 2023