510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN040004Unknown

Celleration Mist Therapy System

Celleration, Inc., Eden Prairie MN / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN040004 is the FDA 510(k) clearance record for CELLERATION MIST THERAPY SYSTEM, a class II device, cleared for Celleration on under FDA product code NRB (Wound Cleaner, Ultrasound). FDA's definition for product code NRB reads: "The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound...". FDA records list 4 510(k) clearances for Celleration, from to . As of , FDA records show no recalls naming DEN040004.

Clearance record

Decision date
Received
(57 days to decision)
Product code
NRB Wound Cleaner, Ultrasound
Regulation
21 CFR 878.4410
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Celleration 6570 Edenvale Blvd., Eden Prairie MN
Third party review
No

Clearances, product code NRB

Trailing 12 months

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

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