510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013360Substantially Equivalent

Dfiner Urological Catheter

Neoseed Technology,Llc, Newburyport MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013360 is the FDA 510(k) clearance record for DFINER UROLOGICAL CATHETER, a class II device, cleared for Neoseed Technology,Llc on under FDA product code FGI (Catheter, Urethrographic, Male). FDA records list one 510(k) clearance for Neoseed Technology,Llc. As of , FDA records show no recalls naming K013360.

Clearance record

Decision date
Received
(133 days to decision)
Product code
FGI Catheter, Urethrographic, Male
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Neoseed Technology,Llc 22 Hill St., Newburyport MA
510(k) summary
Summary
Third party review
No

Clearances, product code FGI

Trailing 12 months

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

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