DeviceClearance

Product code PUB— Obstetrics/Gynecology

G210 InviCell Plus with SignipHy pH monitoring

Classification name
Accessory, Assisted Reproduction, Exempt
Device class
Class 2
Regulation
21 CFR 884.6120
Advisory panel
Obstetrics/Gynecology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PUB under 21 CFR 884.6120, via openFDA

Market context for product code PUB

FDA has cleared 1 device under product code PUB, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PUB

Recent clearances under product code PUB

Data sourced from openFDA. This site is unofficial and independent of the FDA.