Tyrode's Solution-Acidified
by Irvine Scientific Sales Co., Inc.
510(k) K991339
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991339 | Date6 Dec 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
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- Withdrawn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
Overview
AI-generated summary, 1 Oct 2026
Tyrode's Solution-Acidified is a reproductive media device classified as Class II under FDA regulation number 884.6180. It is substantially equivalent to a legally marketed device and was cleared via the traditional 510(k) pathway under K991339.
The device is supplied by Irvine Scientific Sales Co., Inc. and is intended for use in assisted reproductive procedures involving the manipulation of embryos. It is non-sterile, reusable, and stored at room temperature, with no MRI safety information provided in the data.
Other devices from Irvine Scientific Sales Co., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is Tyrode's Solution-Acidified used for?
Tyrode's Solution-Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos, as it is a reproductive media device designed to support embryo handling during such procedures.
Is Tyrode's Solution-Acidified sterile or non-sterile, and is it reusable?
Tyrode's Solution-Acidified is non-sterile and reusable, meaning it is not provided in a sterile condition and can be cleaned and reused for multiple procedures following appropriate laboratory protocols.
How should Tyrode's Solution-Acidified be stored?
Tyrode's Solution-Acidified should be stored at room temperature, as no special temperature conditions such as refrigeration or freezing are indicated in the device data.