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Disposable Semi Automatic Biopsy Instrument

by Suzhou Leapmed Healthcare Corporation

510(k) K212820

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212820↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK212820 Date6 Jul 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Disposable Semi-Automatic Biopsy Instrument, classified under 21 CFR 876.1075 (Biopsy Instruments, Semi-Automatic). It is designed for obtaining tissue samples from internal organs or lesions during minimally invasive procedures, such as ultrasound-guided biopsies. The instrument combines automated and manual functions to facilitate precise tissue acquisition while minimizing operator fatigue. Its disposable design ensures sterility and reduces cross-contamination risks between patients.

The instrument is supplied sterile and intended for single-use only, adhering to FDA 510(k) clearance (K212820) and MDR compliance. It is used in clinical settings such as gastroenterology and urology, where tissue sampling is required for diagnostic purposes. The device is non-magnetic and MRI-safe, allowing for use in environments where imaging compatibility is necessary. Storage instructions specify protection from moisture and extreme temperatures to maintain sterility and functionality.

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