SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
FDA 510(k) clearance K150525 · decided 2015-11-20
Clearance details
- K-number
- K150525
- Device name
- SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-02
- Decision date
- 2015-11-20
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- El Segundo, 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.
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 |