FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
FDA 510(k) clearance K050933 · decided 2005-12-09
Clearance details
- K-number
- K050933
- Device name
- FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
- Applicant
- Medisurg , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-14
- Decision date
- 2005-12-09
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- NCR
- Device class
- 2
- Regulation number
- 886.4100
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Norristown, PA, 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 |
|---|---|---|
| THE FUGO BLADE FOR GLAUCOMA (K041019) | Medisurg , Ltd. | 2004-10-08 |
| THE FUGO BLADE (K001498) | Medisurg , Ltd. | 2000-08-10 |
Recalls involving this device
No recalls on record reference this clearance.