510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871072Substantially Equivalent

Omega Nasal Septal Button

Omega Silicone, Inc., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871072 is the FDA 510(k) clearance record for OMEGA NASAL SEPTAL BUTTON, cleared for Omega Silicone, Inc. on under FDA product code LFB (Button, Nasal Septal). FDA records list 5 510(k) clearances for Omega Silicone, Inc., from to . As of , FDA records show no recalls naming K871072.

Clearance record

Decision date
Received
(82 days to decision)
Product code
LFB Button, Nasal Septal
Device class
Unclassified
Review panel
Unknown
Applicant
Omega Silicone, Inc. 725 Yanonali, Santa Barbara CA
Third party review
No

Clearances, product code LFB

Trailing 12 months

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

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