Cleared Traditional

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument (K223300) - FDA 510(k) Clearance

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

K223300 · Geotek Medikal Ltd Sti · General & Plastic Surgery device
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Apr 2023
Decision
176d
Days
Class 2
Risk

K223300 is an FDA 510(k) clearance for the Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Max.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Geotek Medikal Ltd Sti (Ankara, TR). The FDA issued a Cleared decision on April 21, 2023 after a review of 176 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 Geotek Medikal Ltd Sti devices

Submission Details

510(k) Number K223300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2022
Decision Date April 21, 2023
Days to Decision 176 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
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 Consultant

Licensale, Inc.
Raymond Kelly

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNW Instrument, Biopsy

All 105
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K223300.
SUREcore Prime Biopsy Instrument
K230646 · Uro-1 Medical, Inc. · Nov 2023
EnCor Enspire™Breast Biopsy System (E4115, E4230)
K233220 · Senorx, Inc. · Oct 2023
OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver
K230015 · Laurane Medical Sas · Jun 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
Semi-automatic Biopsy-Needle (BIM 18/20)
K222462 · Itp Innovative Tomography Products GmbH · Jan 2023