DWZ — Device, Biopsy, Endomyocardial Class II

FDA Device Classification

Classification Details

Product Code
DWZ
Device Class
Class II
Regulation Number
870.4075
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252722fehling instrumentsBiopsy ForcepsSeptember 30, 2025
K170726fehling instruments gmbh and co. kgBiopsy ForcepsJune 2, 2017
K072051scholten surgical instrumentsNOVATOME, MODEL: SU101-50October 3, 2007
K010473atc technologiesSPARROWHAWK DISPOSABLEJune 6, 2001
K000409boston scientificMODIFICATION TO T-REX BIOPSY FORCEPSFebruary 28, 2000
K991486medcanicaULTRA-CBXNovember 5, 1999
K973818boston scientificT-REX BIOPSY FORCEPSDecember 16, 1997
K974175heartportHEARTPORT ENDOAORTIC CLAMP CATHETERDecember 16, 1997
K951447portlynDYNABITE CARDIOVASCULAR BIOPSY FORCEPSJuly 27, 1995
K933235cordisCORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIFJanuary 6, 1994
K932788cordisCORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLESeptember 1, 1993
K921401annex medicalBIOPSY FORCEPSOctober 21, 1992
K920289cordisCORDIS BIPAL 7 BIOPSY FORCEPSMarch 30, 1992
K914567cordisCORDIS BIPAL BIOPSY FORCEPSDecember 18, 1991
K910840vascular productsVASCULAR BIOPSY FORCEPSJuly 15, 1991
K901300portlynBIOPSY FORCEPSJune 29, 1990
K895098annex medicalBIOPSY FORCEPSOctober 30, 1989
K890453dlpREUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMESMarch 31, 1989
K883723cookFLEXIBLE MYOCARDIAL BIOPSY FORCEPSDecember 5, 1988
K882383civco medical instruments coMAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDESNovember 28, 1988