510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903749Substantially Equivalent

Islam Sternal Puncture Needle, Cat #Ag-596-00-U

Downs Surgical, Ltd., Sheffield S9 4wj, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903749 is the FDA 510(k) clearance record for ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U, a class I device, cleared for Downs Surgical , Ltd. on under FDA product code GDM (Needle, Aspiration And Injection, Reusable). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K903749.

Clearance record

Decision date
Received
(76 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
Downs Surgical , Ltd. Pkwy. Close,Pkwy., Sheffield S9 4wj, GB
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