510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113508Substantially Equivalent

Dacryocath

Armadillo Biomedical, LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113508 is the FDA 510(k) clearance record for DACRYOCATH, cleared for Armadillo Biomedical, LLC on under FDA product code OKS (Lacrimal Stents And Intubation Sets). FDA's definition for product code OKS reads: "Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such...". FDA records list 2 510(k) clearances for Armadillo Biomedical, LLC, from to . As of , FDA records show no recalls naming K113508.

Clearance record

Decision date
Received
(277 days to decision)
Product code
OKS Lacrimal Stents And Intubation Sets
Device class
Unclassified
Review panel
Unknown
Applicant
Armadillo Biomedical, LLC 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OKS

Trailing 12 months

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

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