Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
K243149 is the FDA 510(k) clearance record for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models), a class II device, cleared for Congruence Medical Solutions, LLC on under FDA product code QLY (Ophthalmic Syringe). FDA's definition for product code QLY reads: "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...". FDA records list one 510(k) clearance for Congruence Medical Solutions, LLC. As of , FDA records show no recalls naming K243149.
Clearance record
- Decision date
- Received
- (81 days to decision)
- Product code
- QLY Ophthalmic Syringe
- Regulation
- 21 CFR 880.5860
- Device class
- Class II
- Review panel
- General Hospital
- Applicant
- Congruence Medical Solutions, LLC 3000 Falls Rd., Baltimore MD
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code QLY
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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