K200242 is an FDA 510(k) clearance for the StaClear Syringe. This device is classified as a Ophthalmic Syringe (Class II - Special Controls, product code QLY).
Submitted by Tribofilm Research, Inc. (Raleigh, US). The FDA issued a Cleared decision on July 27, 2020, 178 days after receiving the submission on January 31, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860. An Ophthalmic Syringe Is A Piston Syringe Intended For Intraocular Injections. The Device Consists Of A Calibrated Hollow Barrel, A Movable Plunger, And May Include A Needle. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye..
| 510(k) Number | K200242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2020 |
| Decision Date | July 27, 2020 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QLY - Ophthalmic Syringe |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| Definition | An Ophthalmic Syringe Is A Piston Syringe Intended For Intraocular Injections. The Device Consists Of A Calibrated Hollow Barrel, A Movable Plunger, And May Include A Needle. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye. |