Gelesis, Inc.: FDA clearances and approvals
Gelesis, Inc. has 1 FDA 510(k) clearance (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 367 days. It is the industry lead sponsor of 8 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 367 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Gelesis, Inc.'s cleared 510(k)s took a median 367 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 283 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFQ | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | 2 | 1 |
Review panels
Most recent Gelesis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230133 | Plenity | QFQ | 2024-01-19 | 367 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180060 | De Novo | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | 2019-04-12 |
Recalls
openFDA lists no recalls under a recalling firm named Gelesis, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Gelesis, Inc. is the industry lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03622424: Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP (Completed, started 2017-08-22)
- NCT03124134: Gelesis Glycemic Index Study (Completed, started 2017-04-18)
- NCT03021291: Extension Study of Gelesis100 on Body Weight (Completed, started 2017-01-25)
- NCT02652962: Gelesis200 Safety and Tolerability Study and Effects on Glycemic and Appetite Parameters (Completed, started 2016-01)
- NCT02524821: The Effect of Gelesis100 on the Pharmacokinetics of Metformin (Completed, started 2015-09)
Frequently asked questions
How many FDA 510(k) clearances does Gelesis, Inc. have?
Gelesis, Inc. has 1 FDA 510(k) clearance (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Gelesis, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gelesis, Inc.'s cleared 510(k)s is 367 days.
What devices does Gelesis, Inc. make?
Its most frequent FDA product codes are QFQ (Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss, 2).
Has Gelesis, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gelesis, Inc. Related entities may recall under other names.
Next steps
- See all 1 Gelesis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QFQ, Gelesis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.