FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLEARCUT S SAFETY KNIFE
K Number: K110166
·
Decision May 20, 2011
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
16
Review Days
120
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Basic Information
- Device Name
- CLEARCUT S SAFETY KNIFE
- K Number
- K110166
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Research, Ltd.
- Date Received
- January 20, 2011
- Decision Date
- May 20, 2011
- Product Code
- HNN
- 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNN), ordered by most recent decision date.
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OPHTHALMIC DISPOSABLE BLADES
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| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | Oct 21, 2010 | Substantially Equivalent |
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