510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K052919Substantially Equivalent

Microsulis Tissue Ablation System

Microsulis Americas, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052919 is the FDA 510(k) clearance record for MICROSULIS TISSUE ABLATION SYSTEM, a class II device, cleared for Microsulis Americas, Inc. on under FDA product code NEY (System, Ablation, Microwave And Accessories). FDA records list one 510(k) clearance for Microsulis Americas, Inc. As of , FDA records show no recalls naming K052919.

Clearance record

Decision date
Received
(88 days to decision)
Product code
NEY System, Ablation, Microwave And Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Microsulis Americas, Inc. 275 Wyman St.,Suite 12, Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEY

Trailing 12 months
2 clearances under product code NEY in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NEY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260