510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964522Substantially Equivalent

Ellipse 4

Andromeda Medizinische Systeme GmbH, Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964522 is the FDA 510(k) clearance record for ELLIPSE 4, a class II device, cleared for Andromeda Medizinische Systeme GmbH on under FDA product code FEN (Device, Cystometric, Hydraulic). FDA records list one 510(k) clearance for Andromeda Medizinische Systeme GmbH. As of , FDA records show no recalls naming K964522.

Clearance record

Decision date
Received
(129 days to decision)
Product code
FEN Device, Cystometric, Hydraulic
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Andromeda Medizinische Systeme GmbH 9109 Copenhaver Dr., Potomac MD
510(k) summary
Summary
Third party review
No

Clearances, product code FEN

Trailing 12 months

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

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