510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771574Substantially Equivalent

Lee Aspiration Needle

Radiation Development Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771574 is the FDA 510(k) clearance record for LEE ASPIRATION NEEDLE, a class I device, cleared for Radiation Development Co., Inc. on under FDA product code GDM (Needle, Aspiration And Injection, Reusable). FDA records list 2 510(k) clearances for Radiation Development Co., Inc., from to . As of , FDA records show no recalls naming K771574.

Clearance record

Decision date
Received
(113 days to decision)
Product code
GDM Needle, Aspiration And Injection, Reusable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Radiation Development Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GDM

Trailing 12 months

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

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