Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)— 510(k) K223612

Name: FDA 510(k) clearance K223612
Creator: U.S. Food and Drug Administration
Published: 2023-02-21

Substantially Equivalent

Ranfac Corporation

FDA 510(k) clearance K223612 for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA), Substantially Equivalent on 2023-02-21. Applicant: Ranfac Corporation. Device class: 2.

Clearance details

Applicant: Ranfac Corporation
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2022-12-05
Decision date: 2023-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Avon, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

view all

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 Ranfac Corporation

view all

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.