Cleared Traditional

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (K230015) - FDA 510(k) Clearance

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

K230015 · Laurane Medical Sas · General & Plastic Surgery device
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Jun 2023
Decision
164d
Days
Class 2
Risk

K230015 is an FDA 510(k) clearance for the OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Laurane Medical Sas (Le Pradet, FR). The FDA issued a Cleared decision on June 16, 2023 after a review of 164 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 Laurane Medical Sas devices

Submission Details

510(k) Number K230015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2023
Decision Date June 16, 2023
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
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 K230015.
M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
K233031 · Canyon Medical, Inc. · Jan 2024
SUREcore Prime Biopsy Instrument
K230646 · Uro-1 Medical, Inc. · Nov 2023
EnCor Enspire™Breast Biopsy System (E4115, E4230)
K233220 · Senorx, Inc. · Oct 2023
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