Streamline Surgical System
FDA 510(k) clearance K211680 · decided 2021-10-08
Clearance details
- K-number
- K211680
- Device name
- Streamline Surgical System
- Applicant
- New World Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-01
- Decision date
- 2021-10-08
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- MRH
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rancho Cucamonga, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OMNI Ultra Surgical System (1-110) (K253760) | Sight Sciences, Inc. | 2026-08-04 |
| VIA360™ Surgical System (K243503) | New World Medical, Inc. | 2025-02-14 |
| OMNI Surgical System (K232214) | Sight Sciences, Inc. | 2023-08-25 |
| TrabEx Pro (K213173) | Microsurgical Technologies, Inc. | 2022-06-08 |
| iPrime Viscodelivery System (K212797) | Glaukos | 2022-01-06 |
| OMNI Surgical System (K202678) | Sight Sciences, Inc. | 2021-03-01 |
| OMNI PLUS Surgical System (K201953) | Sight Sciences, Inc. | 2020-08-11 |
| OMNI Surgical System (K173332) | Sight Sciences, Inc. | 2017-12-21 |
| VISCO 360 Viscosurgical System (K171905) | Sight Sciences, Inc. | 2017-07-27 |
| Viscoelastic Injector (K143205) | Sight Sciences, Inc. | 2014-12-05 |
| VISCOELASTIC INJECTOR (K132494) | Sight Sciences, Inc. | 2013-10-22 |
| ISCIENCE SURGICAL VISCOINJECTOR (K050716) | Iscience Surgical Corporation | 2005-04-21 |
Recalls involving this device
No recalls on record reference this clearance.