510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881784Substantially Equivalent

Klein Needle

E.L. Medico Intl., Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881784 is the FDA 510(k) clearance record for KLEIN NEEDLE, a class I device, cleared for E.L. Medico Intl., Inc. on under FDA product code GDM (Needle, Aspiration And Injection, Reusable). FDA records list 2 510(k) clearances for E.L. Medico Intl., Inc. As of , FDA records show no recalls naming K881784.

Clearance record

Decision date
Received
(219 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
E.L. Medico Intl., Inc. Post Office Box 1268, San Clemente CA
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