510(k) K191020
K191020 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "G210 InviCell Plus with SignipHy pH monitoring". The FDA issued a decision of Substantially Equivalent on January 14, 2020. The device falls under product code PUB (Accessory, Assisted Reproduction, Exempt), a Class II device regulated under 21 CFR 884.6120. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2020
- Date Received
- April 17, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction, Exempt
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type
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 the Physical State field of this product code description.