510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180630Substantially Equivalent

PTFE Surgical Suture

Omnia SRL, Fidenza, IT / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K180630 is the FDA 510(k) clearance record for PTFE SURGICAL SUTURE, a class II device, cleared for Omnia Spa on under FDA product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene). FDA records list one 510(k) clearance for Omnia Spa. As of , FDA records show no recalls naming K180630.

Clearance record

Decision date
Received
(28 days to decision)
Product code
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Regulation
21 CFR 878.5035
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Omnia Spa Via F. Delnevo, 190, Fidenza, IT
510(k) summary
Statement
Third party review
No

Clearances, product code NBY

Trailing 12 months

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

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