FHO · Class II · 21 CFR 876.1500

FDA Product Code FHO: Pneumoperitoneum Needle

For Establishment Of A Pneumoperitoneum In Abdomen.

Leading manufacturers include Origin Medsystems, Inc., Core Dynamics, Inc. and Clarus Medical Systems, Inc..

15
Total
15
Cleared
114d
Avg days
1985
Since

FDA 510(k) Cleared Pneumoperitoneum Needle Devices (Product Code FHO)

15 devices
1–15 of 15
Cleared Aug 05, 1996
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
K960574
Sherwood Medical Co.
Gastroenterology & Urology · 175d
Cleared Jun 24, 1994
VERRES NEEDLE
K942484
Linvatec Corp.
Gastroenterology & Urology · 30d
Cleared Nov 16, 1992
CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE
K915725
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 332d
Cleared Nov 27, 1991
ENTREE NEEDLE
K914426
Core Dynamics, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 08, 1991
ORIGINEEDLE, MODIFICATION
K913816
Origin Medsystems, Inc.
Gastroenterology & Urology · 74d
Cleared Mar 29, 1991
ORIGINEEDLE(TM)
K904849
Origin Medsystems, Inc.
Gastroenterology & Urology · 154d
Cleared Oct 02, 1986
DISPOSABLE PNEUMOPERITONEUM NEEDLE
K863330
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 44d

About Product Code FHO - Regulatory Context