Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Plenity

K-Number: K230133 · 2024-01-19

ApplicantGelesis, Inc.
Decision Date2024-01-19
Product CodeQFQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Plenity is the device name listed in this FDA 510(k) record. The listed applicant is Gelesis, Inc.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) 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. The listed applicant is Gelesis, Inc.. The 510(k) number is K230133.

When did Plenity receive FDA 510(k) clearance?

Plenity received FDA 510(k) clearance on 2024-01-19, under 510(k) number K230133.

Who is the listed applicant for Plenity?

The FDA 510(k) record lists Gelesis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plenity?

The FDA product code for Plenity is QFQ.

Related Devices (Code: QFQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240544EpitomeeEpitomee Medical , Ltd.

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.

↑