510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854238Substantially Equivalent

Needle W/stylet for Implantation

Microvasive, Milford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854238 is the FDA 510(k) clearance record for NEEDLE W/STYLET FOR IMPLANTATION, a class I device, cleared for Microvasive on under FDA product code GAA (Needle, Aspiration And Injection, Disposable). FDA records list 18 510(k) clearances for Microvasive, from to . As of , FDA records show no recalls naming K854238.

Clearance record

Decision date
Received
(23 days to decision)
Product code
GAA Needle, Aspiration And Injection, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Microvasive 31 Maple St., Milford MA
Third party review
No

Clearances, product code GAA

Trailing 12 months

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

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