Cleared Traditional

K222462 - Semi-automatic Biopsy-Needle (BIM 18/20)

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)

K222462 is an FDA 510(k) clearance for Semi-automatic Biopsy-Needle (BIM 18/20), 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 158-day FDA review.

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

FDA 510(k) Submission Details - K222462

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.

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 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