Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles— 510(k) K210946

Clearance details

Applicant

Promisemed Hangzhou Meditech Co., Ltd.

Product code

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2021-03-30

Decision date

2021-08-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou City, CN

• K260517 — Automatic Core Biopsy Instrument2026-08-28
• K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
• K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
• K260572 — Marrow Marxman2026-08-04
• K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

• K261719 — Promisemed X-Safety Pen Needle2026-08-25
• K261045 — Verifine Safety Lancets2026-05-01
• K254273 — Verisafe Safety Sterile Needles (SSN)2026-04-16
• K250192 — Verisafe Safety Retractable Insulin Syringes2025-12-10
• K250961 — Blood collection tube holders2025-06-04

Death

9

Injury

965

Malfunction

10,444

Other

3

Total

11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →