KARL STORZ KNIVES, CURETTES
FDA 510(k) clearance K945686 · decided 1995-02-13
Clearance details
- K-number
- K945686
- Device name
- KARL STORZ KNIVES, CURETTES
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-21
- Decision date
- 1995-02-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- EZO
- Device class
- 2
- Regulation number
- 876.4770
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| URETHROTOME 8667.XXX AND 8670.XXX (K000905) | Richard Wolf Medical Instruments Corp. | 2000-05-12 |
| OES UROLOGY (K950719) | Olympus America, Inc. | 1996-12-11 |
| KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (K934730) | KARL STORZ Endoscopy-America, Inc. | 1994-01-11 |
| FLEXIBLE AND RIGID URETEROTOME SYSTEM (K904939) | Olympus Corp. | 1992-01-07 |
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 |