Who is the manufacturer of MD TECH BIOPSY SET FOR BONE AND BONE MARROW?

Medical Device Technologies, Inc. filed the 510(k) submission for MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K961959).

What is the FDA product code for MD TECH BIOPSY SET FOR BONE AND BONE MARROW?

GAA. It is classified under 21 CFR 878.4800 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MD TECH BIOPSY SET FOR BONE AND BONE MARROW?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MD TECH BIOPSY SET FOR BONE AND BONE MARROW?

Bone Marrow Biopsy Needle (K890925); Super Core Biopsy Needle (K930732); Bone Marrow Harvest Needle (K940025); Monoject Bone Marrow Needle (K945109).

Who can help prepare an FDA 510(k) submission like MD TECH BIOPSY SET FOR BONE AND BONE MARROW?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MD TECH BIOPSY SET FOR BONE AND BONE MARROW

K961959 · Medical Device Technologies, Inc. · GAA · Jul 19, 1996 · General, Plastic Surgery

Device Facts

Record ID	K961959
Device Name	MD TECH BIOPSY SET FOR BONE AND BONE MARROW
Applicant	Medical Device Technologies, Inc.
Product Code	GAA · General, Plastic Surgery
Decision Date	Jul 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4800
Device Class	Class 1

Intended Use

The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.

Device Story

Device: MD Tech Biopsy-Set; percutaneous bone/bone marrow biopsy needle. Operation: mechanical insertion adjacent to biopsy site; mechanical cutting to harvest specimen; negative pressure aspiration via attached syringe to outer cannula. Specimen containment: within outer cannula during withdrawal. Usage: clinical setting; physician-operated. Benefit: facilitates diagnostic tissue sampling.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical biopsy needle; percutaneous insertion; manual operation; utilizes cutting surfaces and negative pressure aspiration via syringe attachment; stainless steel construction (implied by biopsy needle class).

Indications for Use

Indicated for patients requiring bone or bone marrow biopsy/aspiration for diagnostic purposes.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

Bone Marrow Biopsy Needle (K890925)
Super Core Biopsy Needle (K930732)
Bone Marrow Harvest Needle (K940025)
Monoject Bone Marrow Needle (K945109)

Related Devices

K980196 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW · Medical Device Technologies, Inc. · Feb 3, 1998
K962569 — BIOMID BONE MARROW BIOPSY NEEDLE · Gallini Intl., Inc. · Nov 27, 1996
K190177 — J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, · Ranfac Corporation · Jun 12, 2019
K242322 — Bone Marrow Biopsy Needle · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 24, 2025
K962570 — ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE · Gallini Intl., Inc. · Nov 27, 1996

Submission Summary (Full Text)

{0} K961959 JUL 19 1996 # 510(k) SUMMARY APPLICANT: Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, FL 32608 CONTACT: Karl Swartz Quality Assurance Manager TELEPHONE: (352)338-0440 fax (352)338-0662 TRADE NAMES: Medical Device Technologies, Inc. and/or MD TECH Biopsy Set For Bone and Bone Marrow COMMON NAME: Bone and/or bone marrow aspiration/biopsy needles. CLASSIFICATION NAME: Needle, Biopsy, Cardiovascular, No. 79DWO SUBSTANTIAL EQUIVALENCE: | Company Name | Product Name | 510(k) No. | | --- | --- | --- | | Mannan Medical Products | Bone Marrow Biopsy Needle | K890925 | | Mannan Medical Products | Super Core Biopsy Needle | K930732 | | Mannan Medical Products | Bone Marrow Harvest Needle | K940025 | | Sherwood Medical | Monoject Bone Marrow Needle | K945109 | DESCRIPTION OF DEVICE: Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biopsy needles, K944837 The bone biopsy needle is a variation of this needle. The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens. The MD Tech Biopsy-Set Bone and Bone marrow is inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration), which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.