FLEXIBLE AND RIGID URETEROTOME SYSTEM
FDA 510(k) clearance K904939 · decided 1992-01-07
Clearance details
- K-number
- K904939
- Device name
- FLEXIBLE AND RIGID URETEROTOME SYSTEM
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-01
- Decision date
- 1992-01-07
- Days to decision
- 432 days
- Clearance type
- Traditional
- Product code
- EZO
- Device class
- 2
- Regulation number
- 876.4770
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Success, NY, 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 KNIVES, CURETTES (K945686) | KARL STORZ Endoscopy-America, Inc. | 1995-02-13 |
| KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (K934730) | KARL STORZ Endoscopy-America, Inc. | 1994-01-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for us recall (Z-3102-2011) | Olympus America Inc. | 2011-08-31 |