510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K130900Substantially Equivalent

Evicel Application Device

Ethicon Inc (on Behalf of Omrix Biopharaceuticals, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130900 is the FDA 510(k) clearance record for EVICEL APPLICATION DEVICE, a class II device, cleared for Ethicon Inc (On Behalf of Omrix Biopharaceuticals on under FDA product code FMF (Syringe, Piston). FDA records list one 510(k) clearance for Ethicon Inc (On Behalf of Omrix Biopharaceuticals. As of , FDA records show no recalls naming K130900.

Clearance record

Decision date
Received
(134 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Ethicon Inc (On Behalf of Omrix Biopharaceuticals Rte. 22 W., Somerville NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260