Cleared Special

K261196 - Promisemed VeriEcto Automatic Biopsy Needles

K261196 is an FDA 510(k) clearance for Promisemed VeriEcto Automatic Biopsy Ne..., manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Special 510(k) pathway after a 29-day FDA review.

K261196 · Promisemed Hangzhou Meditech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
29d
Days
Class 2
Risk

K261196 is an FDA 510(k) clearance for the Promisemed VeriEcto Automatic Biopsy Needles. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on May 12, 2026 after a review of 29 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Promisemed Hangzhou Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K261196

510(k) Number K261196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2026
Decision Date May 12, 2026
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 Peers - KNW Instrument, Biopsy

All 289
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K261196.
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K262571 · Bard Peripheral Vascular, Inc. · Aug 2026
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
K262792 · Hologic, Inc. · Aug 2026
Marrow Marxman
K260572 · Medimetrix, LLC · Aug 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · Devicor Medical Products, Inc. · Mar 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · Bard Peripheral Vascular, Inc. · Dec 2025