G210 InviCell Plus with SignipHy pH monitoring
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191020 FDA 510(k)
- FDA Product Code
- PUB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6120 FDA 510(k)
- Regulation Number
- 884.6120 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The G210 InviCell Plus with SignipHy pH monitoring is an accessory for assisted reproduction that provides external independent monitoring and can be connected to virtually any log or monitoring system installed in the lab. It is designed to meet increasing demands for monitoring capabilities while maintaining electrical isolation from external systems. The system can be fitted with an accessory that monitors pH by surrogate media samples using a fluorescent marker contained in a disposable sample cup.
The G210 InviCell Plus with SignipHy pH monitoring is supplied as a reusable device and is regulated under FDA 510K clearance with device class 2. It is manufactured by CooperSurgical, Inc. and is intended for use in obstetrics/gynecology settings. The device includes various model numbers and is designed for long-term incubation with CO2/O2 and pH monitoring capabilities.
Frequently asked questions
What is the G210 InviCell Plus with SignipHy pH monitoring used for?
The G210 InviCell Plus is an accessory for assisted reproduction that provides external independent monitoring of incubation conditions. It can be connected to virtually any log or monitoring system in the lab while maintaining electrical isolation, with optional pH monitoring via surrogate media samples.
How is the G210 InviCell Plus supplied and is it reusable?
The G210 InviCell Plus is supplied as a reusable device designed for long-term incubation with CO2/O2 and pH monitoring capabilities. It is regulated under FDA 510K clearance with device class 2 and manufactured by CooperSurgical, Inc.
What monitoring capabilities does the SignipHy pH accessory provide?
The SignipHy pH monitoring accessory monitors pH levels by analyzing surrogate media samples using a fluorescent marker contained in a disposable sample cup. This allows for pH monitoring without direct contact with the culture environment.
What are the regulatory requirements for the G210 InviCell Plus?
The G210 InviCell Plus is regulated under FDA 510K clearance with device class 2. It is intended for use in obstetrics/gynecology settings and has received traditional clearance as substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: G210 InviCell - CooperSurgical, K-SYSTEMS G210 INVICELL USER MANUAL Pdf Download, K-SYSTEMS G210 INVICELL USER MANUAL Pdf Download, CooperSurgical K-Systems G210 InviCell Long Term Incubator ... - Manuals+
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191020 | Class II | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA 510(k) K191020 24 fields · synced Oct 6, 2026