FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
SOFTRANS INJECTOR
K Number: K913626
·
Decision Dec 18, 1991
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
4
Applicant Total
22
Review Days
125
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Basic Information
- Device Name
- SOFTRANS INJECTOR
- K Number
- K913626
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Staar Surgical Co.
- Date Received
- August 15, 1991
- Decision Date
- December 18, 1991
- Product Code
- HQL
- 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 |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |
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CILCO ANTERIOR CHAMBER LENS
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Other Clearances by Staar Surgical Co.
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|---|---|---|---|
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| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Jun 10, 2004 | Substantially Equivalent |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | May 16, 2002 | Substantially Equivalent |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Dec 4, 1998 | 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 |
| K884241 | STAAR PHACO XL SMALL INCISION SYSTEM | Feb 17, 1989 | Substantially Equivalent |
| K875099 | MOLTENO VALVE SETON | Mar 30, 1988 | Substantially Equivalent |