510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830278Substantially Equivalent

Floret Gauze Packing

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

K830278 is the FDA 510(k) clearance record for FLORET GAUZE PACKING, cleared for Ritmed, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 22 510(k) clearances for Ritmed, Inc., from to . As of , FDA records show no recalls naming K830278.

Clearance record

Decision date
Received
(63 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Ritmed, Inc. 803 N. Front St. Suite 3, Mchenry IL
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