Plenity— 510(k) K230133

Substantially Equivalent

Gelesis, Inc.

FDA 510(k) clearance K230133 for Plenity, Substantially Equivalent on 2024-01-19. Applicant: Gelesis, Inc..

Clearance details

Applicant: Gelesis, Inc.
Product code: Code QFQ
Advisory panel: Gastroenterology, Urology
Date received: 2023-01-17
Decision date: 2024-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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