510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083574Substantially Equivalent

Relieva Stratus Microflow Spacer

Acclarent Inc, Rmenlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083574 is the FDA 510(k) clearance record for RELIEVA STRATUS MICROFLOW SPACER, a class I device, cleared for Acclarent, Inc. on under FDA product code KAM (Cannula, Sinus). FDA records list 45 510(k) clearances for Acclarent, Inc., from to . As of , FDA records show no recalls naming K083574.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KAM Cannula, Sinus
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Acclarent, Inc. 1525-B O'Brien Dr., Rmenlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KAM

Trailing 12 months

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

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