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510(k) K942484

Device
VERRES NEEDLE
Applicant
LINVATEC CORP.
510(k) number
K942484
Product code
FHO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-24
Date received
1994-05-25
Regulation
876.1500
Classification name
Pneumoperitoneum Needle
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROL A WEIDEMAN, PH.D.
Address
11311 Concept Blvd. Largo FL US 33773 33773

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
K010779MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGibbons Surgical Corp.2001-04-10
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
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

Legacy Summary#

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FDA Review#

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