← Product Code [GAA](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAA) · K961959

# MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K961959)

_Medical Device Technologies, Inc. · GAA · Jul 19, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAA/K961959

## Device Facts

- **Applicant:** Medical Device Technologies, Inc.
- **Product Code:** [GAA](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAA.md)
- **Decision Date:** Jul 19, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4800
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Indications for 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).

## Regulatory 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](/device/K890925.md))
- Super Core Biopsy Needle ([K930732](/device/K930732.md))
- Bone Marrow Harvest Needle ([K940025](/device/K940025.md))
- Monoject Bone Marrow Needle ([K945109](/device/K945109.md))

## Submission Summary (Full Text)

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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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAA/K961959](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAA/K961959)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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