THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
FDA 510(k) clearance K881014 · decided 1988-04-14
Clearance details
- K-number
- K881014
- Device name
- THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-10
- Decision date
- 1988-04-14
- Days to decision
- 35 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
- Culver City, CA, 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 |
|---|---|---|
| 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 |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |