Plenity
K-Number: K230133 · 2024-01-19
ApplicantGelesis, Inc.
Decision Date2024-01-19
Product CodeQFQ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Plenity is a medical device manufactured by Gelesis, Inc.. It received FDA 510(k) clearance on 2024-01-19 under approval number K230133. The device is classified under product code QFQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Plenity?
Plenity is a medical device that received FDA 510(k) clearance on 2024-01-19. It is manufactured by Gelesis, Inc.. The 510(k) number is K230133.
When was Plenity approved by the FDA?
Plenity received FDA 510(k) clearance on 2024-01-19, under approval number K230133.
What company makes Plenity?
Plenity is manufactured by Gelesis, Inc..
What is the FDA product code for Plenity?
The FDA product code for Plenity is QFQ.
Other Devices by Gelesis, Inc.
Related Devices (Code: QFQ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.