Cleared Traditional

SUREcore Plus Biopsy Instrument (K220611) - FDA 510(k) Clearance

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

K220611 · Uro-1, Inc. · General & Plastic Surgery device
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Dec 2022
Decision
274d
Days
Class 2
Risk

K220611 is an FDA 510(k) clearance for the SUREcore Plus Biopsy Instrument. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Uro-1, Inc. (Greensboro, US). The FDA issued a Cleared decision on December 2, 2022 after a review of 274 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 Uro-1, Inc. devices

Submission Details

510(k) Number K220611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2022
Decision Date December 02, 2022
Days to Decision 274 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
159d slower than avg
Panel avg: 115d · This submission: 274d
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 K220611.
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
NeoNavia Biopsy System
K220595 · Neodynamics AB · Sep 2022
Disposable Semi Automatic Biopsy Instrument
K212820 · Suzhou Leapmed Healthcare Corporation · Jul 2022
NovaCore Semi-Automatic Biopsy Instrument
K213232 · Argon Medical Devices · Jul 2022