3D VIDEO SYSTEM
FDA 510(k) clearance K934883 · decided 1994-03-07
Clearance details
- K-number
- K934883
- Device name
- 3D VIDEO SYSTEM
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-12
- Decision date
- 1994-03-07
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- FWG
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Vernon Hills, IL, 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 |
|---|---|---|
| VIS-2000 VIDEO SYSTEM (K860173) | Vistek Corp. | 1986-02-07 |
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 |