FDA.reportPublic FDA data

510(k) K915142

Device
AMCATH DISPOSABLE BIOPSY FORCEPS
Applicant
INTL. MEDICAL, INC.
510(k) number
K915142
Product code
FCF  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-10
Date received
1991-11-14
Regulation
876.1075
Classification name
Instrument, Biopsy, Mechanical, Gastrointestinal
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
PETER WETTERMANN
Address
175 Connecticut Mills Ave. Danielson CT US 06239 06239

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K070759POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEMVidacare Corporation2007-05-21
K062833POWERED EZ-IO BONE MARROW ASPIRATION SYSTEMVidacare Corporation2006-11-30
K984168BARRETT'S ESOPHAGEAL CYTOLOGY DEVICEUnited States Endoscopy Group, Inc.1999-12-07
K911155OVAL CUP BIOPSY FORCEPEndovations1991-08-07
K843477PHARMA-PLAST RECTAL TIPZimmar Consulting , Ltd.1984-12-05

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