510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191020Substantially Equivalent

G210 InviCell Plus with SignipHy pH monitoring

CooperSurgical, Inc., Trumbull CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191020 is the FDA 510(k) clearance record for G210 InviCell Plus with SignipHy pH monitoring, a class II device, cleared for CooperSurgical, Inc. on under FDA product code PUB (Accessory, Assisted Reproduction, Exempt). FDA's definition for product code PUB reads: "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...". FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show no recalls naming K191020.

Clearance record

Decision date
Received
(272 days to decision)
Product code
PUB Accessory, Assisted Reproduction, Exempt
Regulation
21 CFR 884.6120
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
CooperSurgical, Inc. 95 Corporate Dr., Trumbull CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PUB

Trailing 12 months

FDA records hold no clearances under product code PUB in the trailing twelve months.

FDA records show no clearances under product code PUB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PUB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260