FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ahmed Glaucoma Valve
K Number: K162060
·
Decision Oct 24, 2016
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
12
Review Days
90
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Basic Information
- Device Name
- Ahmed Glaucoma Valve
- K Number
- K162060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3920
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New World Medical, Inc.
- Date Received
- July 26, 2016
- Decision Date
- October 24, 2016
- Product Code
- KYF
- 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 |
|---|---|---|---|
| KYF | Implant, Eye Valve | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
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Other Clearances by New World Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243503 | VIA360 Surgical System | Feb 14, 2025 | Substantially Equivalent |
| K220891 | Kahook Dual Blade Glide (KDB Glide) | May 17, 2024 | Substantially Equivalent |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | May 12, 2023 | Substantially Equivalent |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | May 12, 2023 | Substantially Equivalent |
| K211680 | Streamline Surgical System | Oct 8, 2021 | Substantially Equivalent |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | Jan 18, 2019 | Substantially Equivalent |
| K171451 | Ahmed Glaucoma Valve Model FP8 | Aug 8, 2017 | Substantially Equivalent |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | Sep 18, 2006 | Substantially Equivalent |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | Jul 13, 1999 | Substantially Equivalent |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | Apr 20, 1998 | Substantially Equivalent |