ARTHROSCAN VIDEO SYSTEM
FDA 510(k) clearance K834069 · decided 1984-01-27
Clearance details
- K-number
- K834069
- Device name
- ARTHROSCAN VIDEO SYSTEM
- Applicant
- Concept, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-25
- Decision date
- 1984-01-27
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FWF
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Concept
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FLEXISCOPE, MODELS 50MH AND 50 MHC (K053412) | Schoelly Imaging, Inc. | 2006-02-23 |
| KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (K990154) | Karl Storz Imaging, Inc. | 1999-06-01 |
| EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) (K982754) | A.Stein - Regulatory Affairs Consulting | 1999-01-08 |
| ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (K982965) | Richard Wolf Medical Instruments Corp. | 1998-11-23 |
| VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM (K982397) | Angiolaz, Inc. | 1998-09-10 |
| VES 1501-M (K982409) | Angiolaz, Inc. | 1998-08-21 |
| ANGIOLAZ VES-1CAM (K981819) | Angiolaz, Inc. | 1998-08-04 |
| ISOLATED CAMERA HEAD (K944707) | Envision Medical Corp. | 1994-10-07 |
| FUJINON VIDEO LAPAROSCOPE, MODIFIED (K930297) | Fujinon, Inc. | 1994-03-29 |
| SURGICAL VIDEO CAMERA AND ACCESSORIES (K934682) | Medical Dynamics, Inc. | 1994-02-15 |
| ENDOSCOPIC VIDEO CAMERA (K932628) | Stephen Chakoff, Inc. | 1993-10-15 |
| COAST VIDEO ENDOSCOPIC IMAGING SYSTEM (K926166) | Optik | 1993-06-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HUNTER-SESSIONS VENA-CAVA OCCLUDER (P770005) | Concept, Inc. | 1977-12-19 |