510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230133Substantially Equivalent

Plenity

Gelesis SRL, Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230133 is the FDA 510(k) clearance record for Plenity, a class II device, cleared for Gelesis, Inc. on under FDA product code QFQ (Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss). FDA's definition for product code QFQ reads: "This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract". FDA records list 2 510(k) clearances for Gelesis, Inc., from to . As of , FDA records show no recalls naming K230133.

Clearance record

Decision date
Received
(367 days to decision)
Product code
QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Regulation
21 CFR 876.5982
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gelesis, Inc. 501 Boyston St., Suite 6102, Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFQ

Trailing 12 months

FDA records hold no clearances under product code QFQ in the trailing twelve months.

FDA records show no clearances under product code QFQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260