← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K013070 # JAMSHIDI BIOPSY NEEDLE (K013070) _H.S. Hospital Services S.P.A. · FCG · Dec 12, 2001 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K013070 ## Device Facts - **Applicant:** H.S. Hospital Services S.P.A. - **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md) - **Decision Date:** Dec 12, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow ## Device Story The Jamshidi Bone Marrow Biopsy Needle is a manual surgical instrument designed for the extraction of bone marrow and osteomedullary tissue. It is used by clinicians in a clinical setting to perform biopsy procedures. The device functions as a mechanical tool to penetrate bone and retrieve tissue samples for diagnostic analysis. It does not involve electronic components, software, or automated processing. The output is a physical tissue specimen obtained by the physician, which is subsequently sent to a laboratory for pathological examination to aid in clinical diagnosis and treatment planning. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Manual biopsy needle for bone marrow extraction. Mechanical device; no energy source, software, or connectivity. Materials and dimensions are standard for biopsy instrumentation. ## Regulatory Identification A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Related Devices - [K020987](/device/K020987.md) — BMN I TYPE MARROW ASPIRATION NEEDLE · H.S. Hospital Service S.R.L. · Jun 25, 2002 - [K983187](/device/K983187.md) — MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE · Medsol Corp. · Dec 10, 1998 - [K033616](/device/K033616.md) — TRAPMATIC SYSTEM SET · H.S Hospital Service S.P.A · Mar 1, 2004 - [K990716](/device/K990716.md) — GALLINI BYCUT NEEDLE · Gallini U.S., LLC · May 17, 1999 - [K192099](/device/K192099.md) — MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System · Medax Srl Unipersonale · Apr 2, 2020 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letters "HG" in a bold, stylized font. The letters are interconnected and have a textured, pixelated appearance, giving them a retro or digital feel. There are also horizontal lines below the letters, adding to the design's visual interest. ## PREMARKET NOTIFICATION SUBMISSION - 510 (k) Data: 09-03-2001 # JAMSHIDI™ Pag. 28 di 28 # KO 130 70 ### DEC 1 2 2001 # 510 (k) SUMMARY : H.S. Hospital Service S.p.A. > Applicant Via Naro, 81 - 00040 Pomezia (Rome) Italy : MMC International, LLC > Contact Person Mr. Lucio Improta 10147 Umberland Place - Boca Raton, FL 33428 Tel. (561)477-1671 - Fax. (561)477-0863 e-mail : mmcintern@aol.com : September 03, 2001 > Submission Date : Jamshidi Bone Marrow Biopsy Needle > Trade Name : Bone Marrow Biopsy Needle > Common Name : 876.1075 - Biopsy instrument > Classification Name - * Indication for use : This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 1 2 2001 H.S. Hospital Service S.p.A. c/o Mr. Lucio Improta MMC International, LLC 10147 Umberland Place Boca Raton, Florida 33428 Re: K013070 Korsovo Trade/Device Name: Jamshidi Bone Marrow Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG, KNW Dated: September 3, 2001 Received: September 13, 2001 Dear Mr. Improta: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications ferenced above and nave decemblied the arrest are devices marketed in interstate for use stated in the encrosule) to regally the Medical Device Amendments, or to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recassified in accerative while approval application (PMA).). and Cosmetic Act (Act) that do not require approval of a pressions of the Act . The and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the devices, boyser to the manages and michaeling and general controls provisions of the 110 libeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) the existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation EDA may be subject to such additional bentrelist - Entrologie Parts 800 to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Ood of Pouchar Ing your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issualled of a backed on a bevice complies with other requirements of the Act that FDA has made a decormination administered by other Federal agencies. You must or any Federal statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Act s requirements, mort 801); good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); good if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. Lucio Improta This letter will allow you to begin marketing your device as described in your Section 510(k) The success of the first of a first of a lot stick as well as worldevice of your This letter will anow you to begin marksmig your any as a vour device of your device to a legally premarket notification. The FDA Inding of substantial equal not of the same of thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice lot your do vites diagnostic devices), please contact the Office of additionally 21 CFR Part 809.10 for in vitro diagnostic devices, please cont additionally 21 CFR Part 809.10 think to unestions on the promotion and advertising of Compliance at (301) 594-4659. Additionally, for questions on the promotion and adverti Compliance at (301) 394-4659. Additionally, to: quest (301) 594-4639. Also, please note the your device, prease comact the Orited of concerner to premarket notification' (21CFR Part 807.97). regulation entitled, "Misbranding by reference to the Ast may be obtained f regulation entitled, "Misoranuing of references in and the Act may be obtained from the Other general miormation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Walker, MD Celia M. Witten, Ph.D., M.D. . Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with the letters "JTG" in a bold, sans-serif font. The letters are arranged horizontally, with the "J" on the left, the "T" in the middle, and the "G" on the right. The letters are black and appear to be made up of small dots, giving them a textured look. There are also several horizontal lines below the letters, which are also made up of small dots. #### PREMARKET NOTIFICATION SUBMISSION - 510 (k) #### JAMSHIDI™ 210 (k) # KO130 70 DEVICE NAME Jamshidi Biopsy Needle #### INDICATION FOR USE This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Walk (Division Sign-Off) (Division of General Restorative Division ological Devices 013090 510(k) Number .. **Prescription Use** (Per 21 CFR 801.109) OR Over-The-Counter Use --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K013070](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K013070) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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