MTW · System, Water, Reproduction, Assisted, And Purification
Obstetrics/Gynecology · 21 CFR 884.6170 · Class 2
Overview
| Product Code | MTW |
|---|---|
| Device Name | System, Water, Reproduction, Assisted, And Purification |
| Regulation | 21 CFR 884.6170 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011598 | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE | Irvine Scientific Sales Co., Inc. | Jun 13, 2001 | SESE |
| K993140 | WATER FOR TISSUE CULTURE, MODELS 1500 | Conception Technologies | Aug 2, 2000 | SESE |
Top Applicants
- Conception Technologies — 1 clearance
- Irvine Scientific Sales Co., Inc. — 1 clearance
