FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K Number: K983129
·
Decision Dec 4, 1998
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
22
Review Days
87
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Basic Information
- Device Name
- DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
- K Number
- K983129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Staar Surgical Co.
- Date Received
- September 8, 1998
- Decision Date
- December 4, 1998
- Product Code
- KYB
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
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Other Clearances by Staar Surgical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K090161 | EPIPHANY INJECTION SYSTEM | Jun 9, 2009 | Substantially Equivalent |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | Mar 13, 2008 | Substantially Equivalent |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | Mar 13, 2008 | Substantially Equivalent |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Jun 10, 2004 | Substantially Equivalent |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | May 16, 2002 | Substantially Equivalent |
| K980696 | FOAM TIP INJECTOR | Sep 11, 1998 | Substantially Equivalent |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Dec 21, 1995 | Substantially Equivalent |
| K913626 | SOFTRANS INJECTOR | Dec 18, 1991 | Substantially Equivalent |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | Feb 17, 1989 | Substantially Equivalent |
| K875099 | MOLTENO VALVE SETON | Mar 30, 1988 | Substantially Equivalent |