510(k) Report

FDA applicant

Gelesis, Inc.

Boston, MA3 decisions2019–20260 recalls

FDA records 3 decisions for Gelesis, Inc. (Boston, MA) from 2019 to 2026: 2 510(k) clearances and 1 De Novo grant. All are in product code QFQ (Ingested, Transient, Space Occupying Device…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Gelesis SRL”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Gelesis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12024: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Gelesis, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gelesis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss3decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN180060PlenityGelesis, Inc. · 20192cite it

What has FDA decided for it lately?

  • K261783Plenity-V (MC0979 / GS110)Gelesis SRL · 2026
  • K230133PlenityGelesis, Inc. · 2024
  • DEN180060PlenityGelesis, Inc. · 2019

All 2 as Gelesis, Inc. →The one decision as Gelesis SRL →