Home / 510(k) Clearances / K013360

510(k) K013360

DFINER UROLOGICAL CATHETER by Neoseed Technology,Llc — Product Code FGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2002
Date Received
October 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethrographic, Male
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances for product code FGI

  • K023019 — VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (December 10, 2002)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)