T-REX BIOPSY FORCEPS
FDA 510(k) clearance K973818 · decided 1997-12-16
Clearance details
- K-number
- K973818
- Device name
- T-REX BIOPSY FORCEPS
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1997-10-07
- Decision date
- 1997-12-16
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DWZ
- Device class
- 2
- Regulation number
- 870.4075
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biopsy Forceps (K252722) | Fehling Instruments GmbH | 2025-09-30 |
| Biopsy Forceps (K170726) | Fehling Instruments GmbH & Co. KG | 2017-06-02 |
| NOVATOME, MODEL: SU101-50 (K072051) | Scholten Surgical Instruments, Inc. | 2007-10-03 |
| SPARROWHAWK DISPOSABLE (K010473) | Atc Technologies, Inc. | 2001-06-06 |
| MODIFICATION TO T-REX BIOPSY FORCEPS (K000409) | Boston Scientific Corp | 2000-02-28 |
| ULTRA-CBX (K991486) | Medcanica, Inc. | 1999-11-05 |
| HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175) | Heartport, Inc. | 1997-12-16 |
| DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (K951447) | Portlyn Corp. | 1995-07-27 |
| CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (K933235) | Cordis Corp. | 1994-01-06 |
| CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE (K932788) | Cordis Corp. | 1993-09-01 |
| BIOPSY FORCEPS (K921401) | Annex Medical, Inc. | 1992-10-21 |
| CORDIS BIPAL 7 BIOPSY FORCEPS (K920289) | Cordis Corp. | 1992-03-30 |
Recalls involving this device
No recalls on record reference this clearance.