FHO — Pneumoperitoneum Needle Class II

FDA Device Classification

Classification Details

Product Code
FHO
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

For establishment of a pneumoperitoneum in abdomen.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172120wickimed (huizhou) medical equipment manufacturing coVeress NeedleSeptember 14, 2017
K121370vectecVECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEAugust 2, 2013
K010779gibbons surgicalMODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTApril 10, 2001
K970788apple medicalPNEUMO-MATIC INSUFFLATION NEEDLEMarch 27, 1997
K960574sherwood medicalARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CAugust 5, 1996
K951894micro-medical devicesACCESS EXPANSION SYSTEMJune 15, 1995
K943624henke-sass, wolfELMED PNEUMOPERITONEUM NEEDLESAugust 10, 1994
K942484linvatecVERRES NEEDLEJune 24, 1994
K930474ranfacNEEDLE, PNEUMOPERITONEUM, SPRING LOADEDJuly 23, 1993
K915725clarus medical systemsCLARUS MODELS 1230 AND 1231 LAPARO-NEEDLENovember 16, 1992
K914426core dynamicsENTREE NEEDLENovember 27, 1991
K913816origin medsystemsORIGINEEDLE, MODIFICATIONNovember 8, 1991
K904849origin medsystemsORIGINEEDLE(TM)March 29, 1991
K863330united states surgical, a division of tyco healthcDISPOSABLE PNEUMOPERITONEUM NEEDLEOctober 2, 1986
K844619endotherapeuticsENDONEEDLEJanuary 9, 1985