# LWE · Bone Marrow Collection/Transfusion Kit

_ ·  · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/LWE

## Overview

- **Product Code:** LWE
- **Device Name:** Bone Marrow Collection/Transfusion Kit
- **Regulation:** 21 CFR N/A
- **Device Class:** 2
- **Review Panel:** [](/submissions/)

## Identification

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952350](/device/K952350.md) | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) | Promedical , Ltd. | Jul 17, 1995 | SESE |
| [K913306](/device/K913306.md) | BONE-TEMNO/STERNUM-TEMNO | Proact, Ltd. | Nov 1, 1991 | SESE |
| [K871198](/device/K871198.md) | BONE MARROW COLLECTION KIT AND STAND | Baxter Healthcare Corp | Nov 6, 1987 | SESE |

## Top Applicants

- Baxter Healthcare Corp — 1 clearance
- Proact, Ltd. — 1 clearance
- Promedical , Ltd. — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/LWE](https://fda.innolitics.com/productcode/LWE)

**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).

**Cite:** Innolitics at https://innolitics.com