AUXILIARY INSTRUMENTS FOR URS
FDA 510(k) clearance K971315 · decided 1997-09-15
Clearance details
- K-number
- K971315
- Device name
- AUXILIARY INSTRUMENTS FOR URS
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-09
- Decision date
- 1997-09-15
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- FCL
- Device class
- 1
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 recall (Z-1422-2023) | Richard Wolf GmbH | 2023-04-24 |
| FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 recall (Z-1423-2023) | Richard Wolf GmbH | 2023-04-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |