SURGISIS OCULAR GRAFT
FDA 510(k) clearance K053622 · decided 2006-03-15
Clearance details
- K-number
- K053622
- Device name
- SURGISIS OCULAR GRAFT
- Applicant
- Iop, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-28
- Decision date
- 2006-03-15
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NXM
- Device class
- 2
- Regulation number
- 886.3130
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Costa Mesa, CA, 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 |
|---|---|---|
| KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (K090078) | Iop, Inc. | 2009-05-08 |
Recalls involving this device
No recalls on record reference this clearance.