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FDA 510(k)

Plenity-V (MC0979 / GS110)

K-Number: K261783 · 2026-10-02

ApplicantGelesis SRL
Decision Date2026-10-02
Product CodeQFQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Plenity-V (MC0979 / GS110) is the device name listed in this FDA 510(k) record. The listed applicant is Gelesis SRL. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K261783. 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-V (MC0979 / GS110)?

Plenity-V (MC0979 / GS110) is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Gelesis SRL. The 510(k) number is K261783.

When did Plenity-V (MC0979 / GS110) receive FDA 510(k) clearance?

Plenity-V (MC0979 / GS110) received FDA 510(k) clearance on 2026-10-02, under 510(k) number K261783.

Who is the listed applicant for Plenity-V (MC0979 / GS110)?

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

What is the FDA product code for Plenity-V (MC0979 / GS110)?

The FDA product code for Plenity-V (MC0979 / GS110) is QFQ.

Related Clinical Trials

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.

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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.K230133PlenityGelesis, Inc.

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.

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