G-Thawkit Blast
by Vitrolife AB
510(k) K032155
G-Thawkit Blast is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Vitrolife AB, cleared under FDA 510(k) K032155 on 7 May 2004, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032155 | Date7 May 2004 | StatusActive |
Official records
- FDA 510(k) database K032155
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K032155
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| G-ThawKit Blast 10076 | 10076 | 07350025910178 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code MQL (Media, Reproductive).
- MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL by <Genx> Intl., Inc.
- RAPIDVIT BLAST, RAPIDWARM BLAST by Vitrolife Sweden AB
- SCANDINAVIAN IVF SCIENCES AB, G1.2 by Vitrolife AB/Scandinavian Ivf Sciences AB
- SYNTHETIC SERUM SUBSTITUTE (SSS) by Irvine Scientific Sales Co., Inc.
- VITRIFREEZE MEDIUM; VITRITHAW MEDIUM by Fertipro NV
- OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE by Fertipro NV
- G-2 VERSION 3, MODEL 10049 by Vitrolife Sweden AB
- Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) by DonneVie Medical Technology(Shanghai)Co.Ltd
- HUMAN SERUM ALBUMIN by Advanced Reproductive Technologies
- V-VITFREEZE and V-VITWARM by VITROMED GmbH