510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140020Unknown

Eclipse System

Pelvalon, Hillsborough CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140020 is the FDA 510(k) clearance record for ECLIPSE SYSTEM, a class II device, cleared for Pelvalon on under FDA product code PJH (Dynamic Rectal Control System). FDA's definition for product code PJH reads: "Intended to treat fecal incontinence by controlling the size of the rectal lumen". FDA records list 2 510(k) clearances for Pelvalon, from to . As of , FDA records show no recalls naming DEN140020.

Clearance record

Decision date
Received
(233 days to decision)
Product code
PJH Dynamic Rectal Control System
Regulation
21 CFR 876.5930
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pelvalon 1171 Barroilhet Dr., Hillsborough CA
Third party review
No

Clearances, product code PJH

Trailing 12 months

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

FDA records show no clearances under product code PJH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJH, 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