DWZ — Device, Biopsy, Endomyocardial Class II
FDA product code DWZ covers "Device, Biopsy, Endomyocardial", a Class II medical device regulated under 21 CFR 870.4075. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252722 | fehling instruments | Biopsy Forceps | September 30, 2025 |
| K170726 | fehling instruments gmbh and co. kg | Biopsy Forceps | June 2, 2017 |
| K072051 | scholten surgical instruments | NOVATOME, MODEL: SU101-50 | October 3, 2007 |
| K010473 | atc technologies | SPARROWHAWK DISPOSABLE | June 6, 2001 |
| K000409 | boston scientific | MODIFICATION TO T-REX BIOPSY FORCEPS | February 28, 2000 |
| K991486 | medcanica | ULTRA-CBX | November 5, 1999 |
| K973818 | boston scientific | T-REX BIOPSY FORCEPS | December 16, 1997 |
| K974175 | heartport | HEARTPORT ENDOAORTIC CLAMP CATHETER | December 16, 1997 |
| K951447 | portlyn | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | July 27, 1995 |
| K933235 | cordis | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF | January 6, 1994 |
| K932788 | cordis | CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE | September 1, 1993 |
| K921401 | annex medical | BIOPSY FORCEPS | October 21, 1992 |
| K920289 | cordis | CORDIS BIPAL 7 BIOPSY FORCEPS | March 30, 1992 |
| K914567 | cordis | CORDIS BIPAL BIOPSY FORCEPS | December 18, 1991 |
| K910840 | vascular products | VASCULAR BIOPSY FORCEPS | July 15, 1991 |
| K901300 | portlyn | BIOPSY FORCEPS | June 29, 1990 |
| K895098 | annex medical | BIOPSY FORCEPS | October 30, 1989 |
| K890453 | dlp | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES | March 31, 1989 |
| K883723 | cook | FLEXIBLE MYOCARDIAL BIOPSY FORCEPS | December 5, 1988 |
| K882383 | civco medical instruments co | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | November 28, 1988 |