K191020 is an FDA 510(k) clearance for the G210 InviCell Plus with SignipHy pH monitoring. This device is classified as a Accessory, Assisted Reproduction, Exempt (Class II - Special Controls, product code PUB).
Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on January 14, 2020, 272 days after receiving the submission on April 17, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6120. 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..
| 510(k) Number | K191020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2019 |
| Decision Date | January 14, 2020 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PUB — Accessory, Assisted Reproduction, Exempt |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6120 |
| Definition | 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. |