Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart G — Assisted Reproduction Devices](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices) → [21 CFR 884.6100](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6100) → NNB — Needle, Reproduction, Assisted, Reprocessed

# NNB · Needle, Reproduction, Assisted, Reprocessed

_Obstetrics/Gynecology · 21 CFR 884.6100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/NNB

## Overview

- **Product Code:** NNB
- **Device Name:** Needle, Reproduction, Assisted, Reprocessed
- **Regulation:** [21 CFR 884.6100](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6100)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

## Classification Rationale

Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

## Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/NNB](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/NNB)

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