ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
FDA 510(k) clearance K964276 · decided 1997-11-25
Clearance details
- K-number
- K964276
- Device name
- ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-28
- Decision date
- 1997-11-25
- Days to decision
- 393 days
- Clearance type
- Traditional
- Product code
- HEW
- Device class
- 2
- Regulation number
- 884.1640
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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 |