DWZ · Class II · 21 CFR 870.4075

FDA Product Code DWZ: Device, Biopsy, Endomyocardial

Leading manufacturers include Cordis Corp., Annex Medical, Inc. and Boston Scientific Corp.

23
Total
23
Cleared
98d
Avg days
1981
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 33d recently vs 101d historically

FDA 510(k) Cleared Device, Biopsy, Endomyocardial Devices (Product Code DWZ)

23 devices
1–23 of 23
Cleared Sep 30, 2025
Biopsy Forceps
K252722
Fehling Instruments GmbH
Cardiovascular · 33d
Cleared Jun 02, 2017
Biopsy Forceps
K170726
Fehling Instruments GmbH & Co. KG
Cardiovascular · 85d
Cleared Oct 03, 2007
NOVATOME, MODEL: SU101-50
K072051
Scholten Surgical Instruments, Inc.
Cardiovascular · 69d
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409
Boston Scientific Corp
Cardiovascular · 20d
Cleared Nov 05, 1999
ULTRA-CBX
K991486
Medcanica, Inc.
Cardiovascular · 191d
Cleared Dec 16, 1997
T-REX BIOPSY FORCEPS
K973818
Boston Scientific Corp
Cardiovascular · 70d
Cleared Dec 16, 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175
Heartport, Inc.
Cardiovascular · 40d
Cleared Jan 06, 1994
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
K933235
Cordis Corp.
Cardiovascular · 232d
Cleared Sep 01, 1993
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788
Cordis Corp.
Cardiovascular · 84d
Cleared Oct 21, 1992
BIOPSY FORCEPS
K921401
Annex Medical, Inc.
Cardiovascular · 211d
Cleared Mar 30, 1992
CORDIS BIPAL 7 BIOPSY FORCEPS
K920289
Cordis Corp.
Cardiovascular · 68d
Cleared Dec 18, 1991
CORDIS BIPAL BIOPSY FORCEPS
K914567
Cordis Corp.
Cardiovascular · 64d
Cleared Oct 30, 1989
BIOPSY FORCEPS
K895098
Annex Medical, Inc.
Cardiovascular · 76d
Cleared Mar 31, 1989
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES
K890453
Dlp, Inc.
Cardiovascular · 60d
Cleared Dec 05, 1988
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723
Cook, Inc.
Cardiovascular · 96d
Cleared Nov 28, 1988
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
K882383
CIVCO Medical Instruments Co., Inc.
Cardiovascular · 172d
Cleared Apr 17, 1981
CORDIS BIOPSY FORCEPS
K810849
Cordis Corp.
Cardiovascular · 18d

About Product Code DWZ - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code DWZ since 1981, with 23 receiving FDA clearance (average review time: 98 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DWZ Product Code

Recent submissions under DWZ have taken an average of 33 days to reach a decision - down from 101 days historically, suggesting improved FDA processing for this classification.

DWZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →