# K162588: Möller Medical Biopsy Needles and Systems - Pathway: 510(k) (Traditional) - Applicant: Moller Medical GmbH - Decided: Jun 19, 2017 after 276 days - Product code: KNW (Instrument, Biopsy) - Device class: 2 - Regulation: 21 CFR 876.1075 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K890925 (1989). 33 ancestors in all. 1 later device descends from it; 1 cites it directly. 1 of 35 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K980226: Manan Pro-Mag Automatic Biopsy System, Medical Device Technologies, Inc. (1998) Summary page 6. - K980196: MD Tech Biopsy Set for Bone and Bone Marrow, Medical Device Technologies, Inc. (1998) Summary page 6. - K980122: Manan Soft Tissue Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 6. - K974446: Manan Automatic Cutting Needle, Manan Medical Products, Inc. (1998) Summary page 6. - K111529: Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy Needle Model MCN-, Insert Molding Solutions, Inc. (2011) Summary page 6. - K010735: Speedybell, Biopsybell S.A.S. (2001) Summary page 7. - K130616: Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles, Biopsybell S.R.L. (2014) Summary page 7. - K980004: Manan General Purpose Introducer Needle, Medical Device Technologies, Inc. (1998) Summary page 7. - K960509: 18 Gauge Tru-Cut Biopsy Needle, Baxter Healthcare Corp (1996) Summary page 7. ## Cited in the summary but kept off the family tree - K090487: Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125, C855-5150, Coeur, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (2025), 0 descendants of its own ## Indications for use The Moller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen. Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone respectively bone marrow. Model BOW-1070 bone marrow aspiration biopsy set is intended for aspiration in the area of the sternum or iliac crest. Application areas of the products are bone respectively bone marrow. Model BOY-1080 bone biopsy needle set has been designed for atraumatic bone biopsy. Application areas of the products are bone respectively bone marrow. Model DNG-10XX single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions and are combined with biopsy guns. Model full-sCore® DNG-2020 disposable biopsy needles are intended only for biopsies on soft tissue and tissue from soft, internal organs such as liver, kidney, breast, lung and various soft tissue lesions , and should be used with the Moéller Medical Blue (RBG-1000-10-1000) biopsy gun. Model FNB and MBY single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs like breast, liver, prostate and kidney. Model COX is for safe needle guidance and for taking several biopsy specimens, for example from liver, kidney, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions, with only one single puncture. Model ABG disposable automatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. Model SBG disposable semiautomatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. Model Moller Medical Blue RBG is a reusable, automatic biopsy gun that is intended exclusively for use with DNG-1020 / full-sCore® DNG-2020 disposable needles for core needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures. Source page: https://510kreport.com/device/K162588 Methodology: https://510kreport.com/methodology