G210 InviCell Plus with SignipHy pH monitoring
FDA 510(k) K191020 · CooperSurgical, Inc.
Submission
- Device name
- G210 InviCell Plus with SignipHy pH monitoring
- Applicant
- CooperSurgical, Inc.
Trumbull, CT, US - Received
- April 17, 2019
- Decision date
- January 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PUB – Accessory, Assisted Reproduction, Exempt
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Specialty
- Obstetrics/Gynecology
This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in…
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Questions and answers
When was G210 InviCell Plus with SignipHy pH monitoring cleared by the FDA?
G210 InviCell Plus with SignipHy pH monitoring (K191020) received a 510(k) decision of Substantially Equivalent on January 14, 2020, 272 days after the submission was received.
What is the product code of K191020?
The FDA product code is PUB – Accessory, Assisted Reproduction, Exempt, a Class II (moderate risk) device regulated under 21 CFR 884.6120.