MEDILASE 5010 ENDOSCOPE CONSOLE
FDA 510(k) clearance K900380 · decided 1990-05-15
Clearance details
- K-number
- K900380
- Device name
- MEDILASE 5010 ENDOSCOPE CONSOLE
- Applicant
- Medical Laser, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-26
- Decision date
- 1990-05-15
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| MLI 1000 ND:YAG OP LASER (P830025/S002) | Medical Laser, Inc. | 1985-09-06 |
| MEDITEC OPL3 ND:YAG LASER (P830025/S001) | Medical Laser, Inc. | 1985-06-25 |
| MEDITEC OPL3 ND:YAG LASER (P830025) | Medical Laser, Inc. | 1985-01-14 |