Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003
FDA 510(k) K000420 · Retinalabs.Com
510(k) numberK000420
Submission
- Device name
- Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003
- Applicant
- Retinalabs.Com
Atlanta, GA, US - Received
- February 8, 2000
- Decision date
- May 8, 2000
- 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
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| K211680 | Streamline Surgical SystemMRH · Traditional | New World Medical, Inc. | 10/08/2021SE |
| 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 |
More from Sight Sciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003036 | Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional | 12/22/2000SE |
| K000418 | PDT Dosecalculator, Model 80000NDC · Traditional | 10/24/2000SE |
| K000457 | Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional | 05/09/2000SE |
| K000416 | Transpak (Vitreoretinal Infusion Pak), Models 90000, 90001MPA · Traditional | 05/08/2000SE |
Questions and answers
When was Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003 cleared by the FDA?
Silicone Oil Express (Infusion Pak), Models 10000, 10001, 10002, 10003 (K000420) received a 510(k) decision of Substantially Equivalent on May 8, 2000, 90 days after the submission was received.
What is the product code of K000420?
The FDA product code is MRH – Pump, Infusion, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.