ILWAIT TIMER OCULOPRESSOR
FDA 510(k) clearance K112952 · decided 2012-05-10
Clearance details
- K-number
- K112952
- Device name
- ILWAIT TIMER OCULOPRESSOR
- Applicant
- Oryx Medical Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-05
- Decision date
- 2012-05-10
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- LCC
- Device class
- 2
- Regulation number
- 886.4610
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Maylands, AT
- 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 |
|---|---|---|
| WEE BAG O'MERCURY (K946194) | Microsurgical Technology, Inc. | 1995-02-27 |
| OCULAR PRESSURE REDUCER (MCCANNEL) (K852032) | Visitec Co. | 1985-08-12 |
| WEE BAG O'MERCURY (K840004) | Surgi-Quip Inc.U | 1984-03-22 |
| RELIEF VALVE-HONAN INTRAOC. PRESSURE (K820526) | The Lebanon Corp. | 1982-03-25 |
| NEVYAS AUTOPRESS EYE COMPRESSOR (K792255) | Keeler Optical Products , Ltd. | 1979-12-11 |
Recalls involving this device
No recalls on record reference this clearance.