510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983200Substantially Equivalent

Injection/aspiration Needles Probes/devices-Tpi/tpi Flex

Ximed/Prosure/Injectx, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983200 is the FDA 510(k) clearance record for INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX, a class I device, cleared for Ximed/Prosure/Injectx on under FDA product code GAA (Needle, Aspiration And Injection, Disposable). FDA records list 9 510(k) clearances for Ximed/Prosure/Injectx, from to . As of , FDA records show no recalls naming K983200.

Clearance record

Decision date
Received
(88 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
Ximed/Prosure/Injectx 2195 Trade Zone Blvd., San Jose CA
510(k) summary
Statement
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