URETHROTOME 8667.XXX AND 8670.XXX
FDA 510(k) clearance K000905 · decided 2000-05-12
Clearance details
- K-number
- K000905
- Device name
- URETHROTOME 8667.XXX AND 8670.XXX
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-21
- Decision date
- 2000-05-12
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- EZO
- Device class
- 2
- Regulation number
- 876.4770
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Vernon Hills, IL, 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 |
|---|---|---|
| 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 |
| 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 |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |