Cleared Traditional

VMCore Biopsy Needle (K201650) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201650 · Uro-1, Inc. · Gastroenterology & Urology device
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Jan 2021
Decision
211d
Days
Class 2
Risk

K201650 is an FDA 510(k) clearance for the VMCore Biopsy Needle. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Uro-1, Inc. (Winston Salem, US). The FDA issued a Cleared decision on January 15, 2021 after a review of 211 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Uro-1, Inc. devices

Submission Details

510(k) Number K201650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2020
Decision Date January 15, 2021
Days to Decision 211 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 130d · This submission: 211d
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 Gastroenterology & Urology 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 K201650.
EleVation Breast Biopsy System
K211933 · Bard Peripheral Vascular · Jul 2021
Avitus(r) Bone Harvester
K210631 · Avitus Orthopaedics, Inc. · Mar 2021
EnCor Breast Biopsy Probe with Rinse Tube
K210654 · Senorx, Inc. · Mar 2021
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
K203397 · Biopsybell S.R.L. · Jan 2021
Ran-Flex-B Bone Marrow Aspiration Needle
K202287 · Ranfac Corporation · Sep 2020
Temno Elite Biopsy System
K201166 · Merit Medical Systems, Inc. · Aug 2020