FDA.reportPublic FDA data

510(k) K874063

Device
ENTERON ABDOMINAL PARACENTESIS TRAY
Applicant
ENDOVATIONS
510(k) number
K874063
Product code
KDD  
Decision
Substantially Equivalent - With Drug (SESD)
Decision date
1987-12-04
Date received
1987-10-05
Regulation
878.4800
Classification name
Kit, Surgical Instrument, Disposable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUSAN P BJORKMAN
Address
895 Poplar Church Rd. Camp Hill PA US 17011 17011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidien2008-04-16
K011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.2001-08-13
K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.1997-05-08
K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.1996-04-01
K936255CUSTOM CV PACKAssociated Medical1994-03-31
K932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.1993-07-09
K923176SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.1993-06-17
K925905KIT, SURGICAL INSTRUMENT, DISPOSABLEKay Medical Concepts1993-06-16
K924958BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAYMedical Insights, Inc.1993-06-07
K925215STERILE SURGICAL INSTRUMENT TRAYSAmerican Healthcare Supply Co., Inc.1993-06-01
K924117DEXIDE LAPAROSCOPIC KITSDexide, Inc.1993-03-23
K920989SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.1992-10-19
K920763LACERATTION TRAYSterile Concepts, Inc.1992-09-28
K920516GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSABTrinity Laboratories, Inc.1992-04-16
K914244STERILE CUSTOM SURGICAL KITSUlti-Med Intl., Inc.1992-02-24

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases