THE FUGO BLADE
FDA 510(k) clearance K001498 · decided 2000-08-10
Clearance details
- K-number
- K001498
- Device name
- THE FUGO BLADE
- Applicant
- Medisurg , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-15
- Decision date
- 2000-08-10
- Days to decision
- 87 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
+ Add to Predicate Builder ◉ Watch Medisurg
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 (K050933) | Medisurg , Ltd. | 2005-12-09 |
| THE FUGO BLADE FOR GLAUCOMA (K041019) | Medisurg , Ltd. | 2004-10-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anter recall (Z-1224-06) | Medisurg Research & Management Corp | 2006-08-02 |