Home / 510(k) Clearances / K243936

510(k) K243936

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) by Staclear, Inc. — Product Code QLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2025
Date Received
December 20, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmic Syringe
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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.

Other clearances by Staclear, Inc.

  • K251849 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L (November 21, 2025)

Other clearances for product code QLY

  • K251849 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250L (November 21, 2025)
  • K243322 — Altaviz Intravitreal Syringe (May 9, 2025)
  • K243027 — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC I (April 8, 2025)
  • K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) (December 20, 2024)
  • K230372 — VitreJect Syringe (September 8, 2023)
  • K200242 — StaClear Syringe (July 27, 2020)