510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991613Substantially Equivalent

Sw Ultrasound, Models 331, 311, 333

Starbene, Cordoba, Pvcia. Cordoba, AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991613 is the FDA 510(k) clearance record for SW ULTRASOUND, MODELS 331, 311, 333, a class II device, cleared for Starbene on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 2 510(k) clearances for Starbene, from to . As of , FDA records show no recalls naming K991613.

Clearance record

Decision date
Received
(578 days to decision)
Product code
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Starbene David Luque 519, Cordoba, Pvcia. Cordoba, AR
510(k) summary
Summary
Third party review
No

Clearances, product code IMI

Trailing 12 months

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

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