510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150558Substantially Equivalent

Eclipse System

Pelvalon, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150558 is the FDA 510(k) clearance record for Eclipse System, a class II device, cleared for Pelvalon, Inc. 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, Inc., from to . As of , FDA records show no recalls naming K150558.

Clearance record

Decision date
Received
(253 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, Inc. 923 Thompson Pl., Sunnyvale CA
510(k) summary
Summary PDF
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