Cleared Traditional

Semi-automatic Biopsy-Needle (BIM 18/20) (K222462) - FDA 510(k) Clearance

Also marketed or referenced as:
Semi-automatic Biopsy-Needle (BIM 18.15) Semi-automatic Biopsy-Needle (BIM 18/10) Semi-automatic Biopsy-Needle (BIM 16/20) Semi-automatic Biopsy-Needle (BIM 16/15) Semi-automatic Biopsy-Needle (BIM 16/10) Semi-automatic Biopsy-Needle (BIM 14/20) Semi-automatic Biopsy-Needle (BIM 14/15) Semi-automatic Biopsy-Needle (BIM 14/10)

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

K222462 · Itp Innovative Tomography Products GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
158d
Days
Class 2
Risk

K222462 is an FDA 510(k) clearance for the Semi-automatic Biopsy-Needle (BIM 18/20). 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 January 20, 2023 after a review of 158 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 K222462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date January 20, 2023
Days to Decision 158 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
43d slower than avg
Panel avg: 115d · This submission: 158d
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 K222462.
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
K223300 · Geotek Medikal Ltd Sti · Apr 2023
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
K222865 · Canyon Medical, Inc. · Apr 2023
Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
K223612 · Ranfac Corporation · Feb 2023
SUREcore Plus Biopsy Instrument
K220611 · Uro-1, Inc. · Dec 2022
NeoNavia Biopsy System
K220595 · Neodynamics AB · Sep 2022
Disposable Semi Automatic Biopsy Instrument
K212820 · Suzhou Leapmed Healthcare Corporation · Jul 2022