← Product Code [MQF](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF) · K000656

# EMBRYON GIFT TRANSFER CATHETERS/SETS (K000656)

_Rocket Medical Plc · MQF · Mar 9, 2000 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF/K000656

## Device Facts

- **Applicant:** Rocket Medical Plc
- **Product Code:** [MQF](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF.md)
- **Decision Date:** Mar 9, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.6110
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

## Special Controls

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

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF/K000656](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQF/K000656)

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