Streamline Surgical System
FDA 510(k) K211680 · New World Medical, Inc.
510(k) numberK211680
Submission
- Device name
- Streamline Surgical System
- Applicant
- New World Medical, Inc.
Rancho Cucamonga, CA, US - Received
- June 1, 2021
- Decision date
- October 8, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRH – Pump, Infusion, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MRH
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|---|---|---|---|
| K253760 | OMNI Ultra Surgical System (1-110)MRH · Traditional | Sight Sciences, Inc. | 08/04/2026SE |
| K243503 | VIA360 Surgical SystemMRH · Traditional | New World Medical, Inc. | 02/14/2025SE |
| K232214 | OMNI Surgical SystemMRH · Special | Sight Sciences, Inc. | 08/25/2023SE |
| K213173 | TrabEx ProMRH · Traditional | Microsurgical Technologies, Inc. | 06/08/2022SE |
| K212797 | iPrime Viscodelivery SystemMRH · Traditional | Glaukos | 01/06/2022SE |
| K202678 | OMNI Surgical SystemMRH · Traditional | Sight Sciences, Inc. | 03/01/2021SE |
| K201953 | OMNI PLUS Surgical SystemMRH · Special | Sight Sciences, Inc. | 08/11/2020SE |
| K173332 | OMNI Surgical SystemMRH · Traditional | Sight Sciences, Inc. | 12/21/2017SE |
| K171905 | VISCO 360 Viscosurgical SystemMRH · Special | Sight Sciences, Inc. | 07/27/2017SE |
| K143205 | Viscoelastic InjectorMRH · Special | Sight Sciences, Inc. | 12/05/2014SE |
More from Sight Sciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243503 | VIA360 Surgical SystemMRH · Traditional | 02/14/2025SE |
| K220891 | Kahook Dual Blade Glide (KDB Glide)QUQ · Traditional | 05/17/2024SE |
| K231051 | Ahmed® Glaucoma Valve Model FP8KYF · Special | 05/12/2023SE |
| K230975 | Ahmed® Glaucoma Valve Model FP7KYF · Special | 05/12/2023SE |
| K182518 | AHMED ClearPath Glaucoma Drainage DeviceKYF · Traditional | 01/18/2019SE |
| K171451 | Ahmed Glaucoma Valve Model FP8KYF · Traditional | 08/08/2017SE |
| K162060 | Ahmed Glaucoma ValveKYF · Traditional | 10/24/2016SE |
| K060644 | Ahmed Glaucoma Valve, Model M4KYF · Traditional | 09/18/2006SE |
| K991072 | Ahmed Glaucoma Valve ImplantKYF · Traditional | 07/13/1999SE |
| K980657 | Ahmed Glaucoma Valve, Model S3KYF · Traditional | 04/20/1998SE |
Questions and answers
When was Streamline Surgical System cleared by the FDA?
Streamline Surgical System (K211680) received a 510(k) decision of Substantially Equivalent on October 8, 2021, 129 days after the submission was received.
What is the product code of K211680?
The FDA product code is MRH – Pump, Infusion, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.