Cleared Traditional

K191020 - G210 InviCell Plus with SignipHy pH monitoring (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191020 · CooperSurgical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
272d
Days
Class 2
Risk

K191020 is an FDA 510(k) clearance for the G210 InviCell Plus with SignipHy pH monitoring. Classified as Accessory, Assisted Reproduction, Exempt (product code PUB), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on January 14, 2020 after a review of 272 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all CooperSurgical, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 160d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PUB Accessory, Assisted Reproduction, Exempt
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.