Cleared Traditional

K223300 - Estacore-Pro Automatic Biopsy Needle

K223300 is an FDA 510(k) clearance for Estacore-Pro Automatic Biopsy Needle, manufactured by Geotek Medikal Ltd Sti. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K223300 · Geotek Medikal Ltd Sti · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K223300

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.

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 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 186
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)
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OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver
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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
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