MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
FDA 510(k) clearance K030179 · decided 2003-01-24
Clearance details
- K-number
- K030179
- Device name
- MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-01-17
- Decision date
- 2003-01-24
- Days to decision
- 7 days
- Clearance type
- Abbreviated
- Product code
- NKX
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sisters, OR, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Surgical Instruments Service and Savings
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| VANGUARD REPROCESSED PHACOEMULSIFICATION (K012698) | Vanguard Medical Concepts, Inc. | 2001-11-09 |
| REPROCESSED PHACO TIPS (K012579) | Sterilmed, Inc. | 2001-11-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8 recall (Z-1642-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |