Disposable Automatic Core Biopsy Instrument— 510(k) K212284

Name: FDA 510(k) clearance K212284
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Substantially Equivalent

Suzhou Leapmed Healthcare Corporation

FDA 510(k) clearance K212284 for Disposable Automatic Core Biopsy Instrument, Substantially Equivalent on 2021-11-10. Applicant: Suzhou Leapmed Healthcare Corporation. Device class: 2.

Clearance details

Applicant: Suzhou Leapmed Healthcare Corporation
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2021-07-21
Decision date: 2021-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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 Suzhou Leapmed Healthcare Corporation

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K212819 — Disposable Biopsy Refill Needle2022-07-06
K212820 — Disposable Semi Automatic Biopsy Instrument2022-07-06
K212822 — Disposable Coaxial Biopsy Needle2022-07-06

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.