510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K094021Substantially Equivalent

Acculis Accu2i Pmta Applicator Model Accu2i

Microsulis Medical Limited, Denmead Hampshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K094021 is the FDA 510(k) clearance record for ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I, a class II device, cleared for Microsulis Medical Limited on under FDA product code NEY (System, Ablation, Microwave And Accessories). FDA records list 2 510(k) clearances for Microsulis Medical Limited, from to . As of , FDA records show 6 recalls naming K094021.

Clearance record

Decision date
Received
(219 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 Medical Limited Units 1 & 2 Falcon Ct., Denmead Hampshire, GB
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