REPROCESSED PHACO TIPS
FDA 510(k) clearance K012579 · decided 2001-11-08
Clearance details
- K-number
- K012579
- Device name
- REPROCESSED PHACO TIPS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-09
- Decision date
- 2001-11-08
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- NKX
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Maple Grove, 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.
| Record | Firm | Date |
|---|---|---|
| REPROCESSED PHACOEMULSIFICATION TIPS (K060648) | Alliance Medical Corp. | 2007-03-19 |
| REPROCESSED PHACOEMUISIFICATION TIPS (K050518) | Alliance Medical, Inc. | 2005-09-23 |
| MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (K030179) | Surgical Instruments Service and Savings, Inc. | 2003-01-24 |
| VANGUARD REPROCESSED PHACOEMULSIFICATION (K012698) | Vanguard Medical Concepts, Inc. | 2001-11-09 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC recall (Z-0565-2009) | Sterilmed Inc | 2009-01-13 |