510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953501Substantially Equivalent

Adi Sterile Gauze Sponges

Asia Dynamics Inc., Niles IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953501 is the FDA 510(k) clearance record for ADI STERILE GAUZE SPONGES, cleared for Asia Dynamics, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 4 510(k) clearances for Asia Dynamics, Inc., from to . As of , FDA records show no recalls naming K953501.

Clearance record

Decision date
Received
(33 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Asia Dynamics, Inc. 5745 W. Howard St., Niles 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