GM501 Wash with Phenol Red and Gentamicin
FDA 510(k) K192503 · Hamilton Thorne Incorporated
510(k) numberK192503
Submission
- Device name
- GM501 Wash with Phenol Red and Gentamicin
- Applicant
- Hamilton Thorne Incorporated
Beverly, MA, US - Received
- September 12, 2019
- Decision date
- November 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQL – Media, Reproductive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6180
- Specialty
- Obstetrics/Gynecology
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| K250445 | Fast Warm - NXMQL · Traditional | Fujifilm Irvine Scientific | 09/12/2025SE |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 08/27/2025SE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 08/26/2025SE |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional | Fertipro NV | 05/30/2025SE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 04/10/2025SE |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional | Jiangsu Ruifuda Medical Device Co., Ltd. | 04/10/2025SE |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional | Casebioscience, Inc. | 03/21/2025SE |
More from Casebioscience, Inc.
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| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)MRX · Traditional | 07/02/2021SE |
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| K191552 | GM501 Mineral OilMQL · Abbreviated | 09/18/2019SE |
| K190383 | GM501 WashMQL · Traditional | 09/05/2019SE |
| K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-Tk Hamilton Thorne Infrared Laser…MRX · Traditional | 04/24/2012SE |
Questions and answers
When was GM501 Wash with Phenol Red and Gentamicin cleared by the FDA?
GM501 Wash with Phenol Red and Gentamicin (K192503) received a 510(k) decision of Substantially Equivalent on November 19, 2020, 434 days after the submission was received.
What is the product code of K192503?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.