FDA.reportPublic FDA data

510(k) K982142

Device
MOUNTABLE ENDOSCOPIC KNIFE
Applicant
A.M. SURGICAL, INC.
510(k) number
K982142
Product code
EMF  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-30
Date received
1998-06-17
Regulation
878.4800
Classification name
Knife, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
EUGENE T KING
Address
290 E. Main St. Suite 200 Smithtown NY US 11787 11787

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EMF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080133MOUNTABLE ENDOSCOPIC BLADEA.M. Surgical, Inc.2008-03-13
K890214MICROSURGERY RAZOR BLADE HOLDERKinetic Medical Products1989-01-27
K890215MICROSURGICAL SCARIFIERKinetic Medical Products1989-01-27
K890217MICROSURGICAL KNIVESKinetic Medical Products1989-01-27
K880094VAN-TEC ENDOPYELOTOMY KNIFEVan-Tec, Inc.1988-02-29
K863752VALTRAC (BAR) REMOVER DEVICEDavis & Geck, Inc.1986-10-24
K863549REUSABLE/DISPOSABLE AUTOPSY KNIFE SETSurgipath Medical Industries, Inc.1986-09-30
K861947SURGICAL KNIFESharpoint, Inc.1986-06-06
K854891KNIFEEuro-Med Intl.1986-05-02
K85178427-210 PLASTER KNIFE (REINER)Artiberia1985-06-20
K843497SURGICAL KNIVES & PROBESEder Instrument Co, Inc.1984-10-31
K843371VALVOTOMY KNIFEDowns Surgical , Ltd.1984-10-25
K834184H.R. JAKOBI SURG. INSTRUMENTS #11 38/67Imm Enterprises , Ltd.1984-01-27
K834197JAKOBI SURG. INSTR- #11 38/39/45/46/67Imm Enterprises , Ltd.1984-01-27
K832368CHANGING METHOD OF STERILITY RELEASEDevon Industries, Inc.1983-10-31

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