FDA.reportPublic FDA data

510(k) K010779

Device
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
Applicant
Gibbons Surgical Corp.
510(k) number
K010779
Product code
FHO
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-10
Date received
2001-03-15
Regulation
876.1500
Classification name
Pneumoperitoneum Needle
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
LISA CRISSON
Address
1112 Jensen Dr., Suite 101 Virginia Beach VA US 23451 23451

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FHO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2017-09-14
K121370VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectec2013-08-02
K970788PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.1997-03-27
K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.1996-08-05
K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, Inc.1995-06-15
K943624ELMED PNEUMOPERITONEUM NEEDLESHenke-Sass, Wolf GmbH1994-08-10
K942484VERRES NEEDLELinvatec Corp.1994-06-24
K930474NEEDLE, PNEUMOPERITONEUM, SPRING LOADEDRanfac, Corp.1993-07-23
K915725CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLEClarus Medical Systems, Inc.1992-11-16
K914426ENTREE NEEDLECore Dynamics, Inc.1991-11-27
K913816ORIGINEEDLE, MODIFICATIONOrigin Medsystems, Inc.1991-11-08
K904849ORIGINEEDLE(TM)Origin Medsystems, Inc.1991-03-29
K863330DISPOSABLE PNEUMOPERITONEUM NEEDLEUnited States Surgical, A Division of Tyco Healthc1986-10-02
K844619ENDONEEDLEEndotherapeutics1985-01-09