Cleared Traditional

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM (K233294) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 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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K230646 · Uro-1 Medical, Inc. · Nov 2023
EnCor Enspire™Breast Biopsy System (E4115, E4230)
K233220 · Senorx, Inc. · Oct 2023