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510(k) K191020

G210 InviCell Plus with SignipHy pH monitoring by CooperSurgical, Inc. — Product Code PUB

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.

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