Reprocessed Phacoemuisification Tips
FDA 510(k) K050518 · Alliance Medical, Inc.
510(k) numberK050518
Submission
- Device name
- Reprocessed Phacoemuisification Tips
- Applicant
- Alliance Medical, Inc.
Phoenix, AZ, US - Received
- March 1, 2005
- Decision date
- September 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKX – Needle, Phacoemulsification, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at…
Other 510(k)s with product code NKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060648 | Reprocessed Phacoemulsification TipsNKX · Traditional | Alliance Medical Corp. | 03/19/2007SE |
| K030179 | Medisiss Phacoemulsification Tips/NeedlesNKX · Abbreviated | Surgical Instruments Service and Savings, Inc. | 01/24/2003SE |
| K012698 | Vanguard Reprocessed PhacoemulsificationNKX · Traditional | Vanguard Medical Concepts, Inc. | 11/09/2001SE |
| K012579 | Reprocessed Phaco TipsNKX · Traditional | Sterilmed, Inc. | 11/08/2001SE |
More from Sterilmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060648 | Reprocessed Phacoemulsification TipsNKX · Traditional | 03/19/2007SE |
| K061045 | Reprocessed Electrophysiology CathetersNLH · Traditional | 08/31/2006SE |
| K051438 | Vanguard Reprocessed Compression Garments (Hill-Rom)JOW · Traditional | 04/04/2006SE |
| K060049 | Reprocessed Compression SleevesJOW · Traditional | 02/24/2006SE |
| K060091 | Alliance Medical Corporation Reprocessed Compression SleevesJOW · Traditional | 02/17/2006SE |
| K053316 | Reprocessed Compression SleevesJOW · Traditional | 02/13/2006SE |
| K052918 | Reprocessed External Fixation DevicesKTT · Traditional | 01/27/2006SE |
| K052603 | Reprocessed Daig Livewire Electrophysiology CathetersNLH · Traditional | 11/16/2005SE |
| K052414 | Reprocessed Electrophysiology CatheterNLH · Traditional | 11/16/2005SE |
| K052064 | Alliance Medical Corporation Reprocessed External Fixation DevicesKTT · Special | 08/25/2005SE |
Questions and answers
When was Reprocessed Phacoemuisification Tips cleared by the FDA?
Reprocessed Phacoemuisification Tips (K050518) received a 510(k) decision of Substantially Equivalent on September 23, 2005, 206 days after the submission was received.
What is the product code of K050518?
The FDA product code is NKX – Needle, Phacoemulsification, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 886.4670.