iStent infinite Trabecular Micro-Bypass System, Model iS3
FDA 510(k) clearance K220032 · decided 2022-08-02
Clearance details
- K-number
- K220032
- Device name
- iStent infinite Trabecular Micro-Bypass System, Model iS3
- Applicant
- Glaukos Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-01-05
- Decision date
- 2022-08-02
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| iStent inject® W Trabecular Micro-Bypass System Model iS2 (P170043/S019) | Glaukos Corporation | 2025-02-24 |
| iStent inject Trabecular MicroBypass System (P170043/S020) | Glaukos Corporation | 2025-01-13 |
| iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100 (P080030/S026) | Glaukos Corporation | 2024-03-28 |
| Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System (P170043/S018) | Glaukos Corporation | 2023-12-20 |
| iStent inject® W Trabecular Micro-Bypass System (P170043/S017) | Glaukos Corporation | 2023-07-14 |
| iStent inject® W Trabecular Micro-Bypass System (P170043/S016) | Glaukos Corporation | 2023-07-13 |
| iStent inject W Trabecular Micro-Bypass System (P170043/S013) | Glaukos Corporation | 2022-11-07 |
| iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi (P170043/S014) | Glaukos Corporation | 2022-08-29 |