Part 884 Subpart G—Assisted Reproduction Devices
FDA submissions for Part 884 Subpart G—Assisted Reproduction Devices in the Obstetrics/Gynecology (OB) review panel, including product codes and regulations.
Section range: §§ 884.6100–884.6200
CFR Part: 884
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| MQE | Needle, Assisted Reproduction | 884.6100 | 2 | 32 |
| NNB | Needle, Reproduction, Assisted, Reprocessed | 884.6100 | 2 | 0 |
| MQF | Catheter, Assisted Reproduction | 884.6110 | 2 | 53 |
| QYZ | At Home Intravaginal Insemination System | 884.6110 | 2 | 3 |
| MQG | Accessory, Assisted Reproduction | 884.6120 | 2 | 45 |
| PUB | Accessory, Assisted Reproduction, Exempt | 884.6120 | 2 | 1 |
| QKH | Assisted Reproduction Laminar Flow Workstation | 884.6120 | 2 | 0 |
| QUJ | Automated Cryopreservation Storage System | 884.6120 | 2 | 1 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 884.6130 | 2 | 26 |
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | 884.6130 | 2 | 0 |
| MQI | Microtool Fabrication, Assisted Reproduction | 884.6140 | 2 | 0 |
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 884.6150 | 2 | 23 |
| MQK | Labware, Assisted Reproduction | 884.6160 | 2 | 50 |
| PUD | Labware, Assisted Reproduction, Exempt | 884.6160 | 2 | 0 |
| OYO | Culture, Intravaginal, Assisted Reproduction | 884.6165 | 2 | 2 |
| MTW | System, Water, Reproduction, Assisted, And Purification | 884.6170 | 2 | 2 |
| MQL | Media, Reproductive | 884.6180 | 2 | 258 |
| QKI | Media, Reproductive, Exempt | 884.6180 | 2 | 0 |
| MTX | Microscope And Microscope Accessories, Reproduction, Assisted | 884.6190 | 1 | 0 |
| PBH | Embryo Image Assessment System, Assisted Reproduction | 884.6195 | 2 | 4 |
| MRX | System, Assisted Reproduction Laser | 884.6200 | 2 | 10 |
