Promisemed Fine Biopsy Needle— 510(k) K213683

Name: FDA 510(k) clearance K213683
Creator: U.S. Food and Drug Administration
Published: 2022-04-22

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K213683 for Promisemed Fine Biopsy Needle, Substantially Equivalent on 2022-04-22. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.

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: 2021-11-22
Decision date: 2022-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

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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

More clearances from Promisemed Hangzhou Meditech Co., Ltd.

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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

Adverse events under product code KNW

product code KNW

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.