Vanguard Reprocessed Phacoemulsification
FDA 510(k) K012698 · Vanguard Medical Concepts, Inc.
Submission
- Device name
- Vanguard Reprocessed Phacoemulsification
- Applicant
- Vanguard Medical Concepts, Inc.
Lakeland, FL, US - Received
- August 14, 2001
- Decision date
- November 9, 2001
- 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 |
| K050518 | Reprocessed Phacoemuisification TipsNKX · Traditional | Alliance Medical, Inc. | 09/23/2005SE |
| K030179 | Medisiss Phacoemulsification Tips/NeedlesNKX · Abbreviated | Surgical Instruments Service and Savings, Inc. | 01/24/2003SE |
| K012579 | Reprocessed Phaco TipsNKX · Traditional | Sterilmed, Inc. | 11/08/2001SE |
More from Sterilmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K053051 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 12/22/2005SE |
| K051616 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 09/06/2005SE |
| K051180 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 07/22/2005SE |
| K051043 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/06/2005SE |
| K050763 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/01/2005SE |
| K043198 | Vanguard Reprocessed Arthroscopic WandsNUJ · Traditional | 05/27/2005SE |
| K043253 | Vanguard Reprocessed Dilating Tip and Blunt TrocarsNLM · Traditional | 04/08/2005SE |
| K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesNLM · Traditional | 03/31/2005SE |
| K043315 | Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
| K043225 | Vanguard Reprocessed Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
Questions and answers
When was Vanguard Reprocessed Phacoemulsification cleared by the FDA?
Vanguard Reprocessed Phacoemulsification (K012698) received a 510(k) decision of Substantially Equivalent on November 9, 2001, 87 days after the submission was received.
What is the product code of K012698?
The FDA product code is NKX – Needle, Phacoemulsification, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 886.4670.