510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990584Substantially Equivalent

Gauze Sponges: Laparotomy Sponge, X-Ray Detectable

Broadline Medical Industries, Inverness IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990584 is the FDA 510(k) clearance record for GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE, cleared for Broadline Medical Industries on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 2 510(k) clearances for Broadline Medical Industries, from to . As of , FDA records show no recalls naming K990584.

Clearance record

Decision date
Received
(59 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Broadline Medical Industries 1432 Shire Cir., Inverness IL
510(k) summary
Statement
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

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