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510(k) Data Aggregation
K Number
K243322Device Name
Altaviz Intravitreal Syringe
Manufacturer
Altaviz, LLC
Date Cleared
2025-05-09
(198 days)
Product Code
QLY, FMF
Regulation Number
880.5860Why did this record match?
Product Code :
QLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.
Device Description
The Altaviz Intravitreal Syringe is a three-piece sterile, single use, hypodermic syringe with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assembly consists of a lubricated polycarbonate barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the Altaviz Intravitreal Syringe incorporates a scale graduated in units of milliliters and is provided sterile by an irradiation sterilization method. The only difference between the Altaviz Intravitreal Syringe and the BD 1mL Luer-Lok Syringe is that the Altaviz Intravitreal Syringe is routinely tested to, and must meet, additional requirements to support intraocular use including endotoxin and particulate matter. The Altaviz Intravitreal Syringe is provided sterile by irradiation sterilization.
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K Number
K243027Device Name
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
Manufacturer
Hangzhou Sightnovo Medical Technology Co., Ltd.
Date Cleared
2025-04-08
(193 days)
Product Code
QLY, FMF, FMI
Regulation Number
880.5860Why did this record match?
Product Code :
QLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for use by health care professionals for puncture, drainage and fluid collection of the anterior chamber of the eye. Its operation is manual. The Disposable Aqueous Humor Collector is single use only. The Disposable Aqueous Humor Collector is suitable for ophthalmic use.
Device Description
Disposable aqueous humor collector is composed of a liquid collecting needle sheath, a liquid collecting needle, a needle seat, a liquid collecting needle rubber sheath, a rubber plug, a liquid collecting tube, a cylinder body, a rubber ring, push rod and buckle structure.
Models: SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27
Volume: 50μL, 100μL
Needle Gauge: 25G, 27G
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K Number
K243936Device Name
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Manufacturer
StaClear, INC.
Date Cleared
2025-04-03
(104 days)
Product Code
QLY, FMF, FMI
Regulation Number
880.5860Why did this record match?
Product Code :
QLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
Device Description
The StaClear Syringe is a single-use piston syringe intended for use by healthcare professionals for general-purpose fluid aspiration/injection. Its operation is manual. The StaClear Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. It uses standard syringe components with a low-particulate gas plasma crosslinked silicone coating called TriboLink-Si. The StaClear Syringe is suitable for ophthalmic use.
The StaClear Syringe is offered in the following configurations:
- SC250AN – Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap.
- SC250LS – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
- SC250LL – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.
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K Number
K243149Device Name
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
Manufacturer
Congruence Medical Solutions, LLC
Date Cleared
2024-12-20
(81 days)
Product Code
QLY, FMF
Regulation Number
880.5860Why did this record match?
Product Code :
QLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.
Device Description
The Microliter Dosing Syringe is a single-use, piston syringe-based device consisting of a syringe barrel, plunger stopper, syringe tip cap and incorporates a plunger rod subassembly. It is intended for use by healthcare professionals for general purpose fluid aspiration/injection. Its operation is manual. The Microliter Dosing Syringe is single use only, non-toxic, non-pyrogenic and sterilized by e-beam irradiation. The Microliter Dosing Syringe is suitable for ophthalmic use.
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K Number
K230372Device Name
VitreJect Syringe
Manufacturer
OcuJect, LLC
Date Cleared
2023-09-08
(207 days)
Product Code
QLY, FMF, QNQ
Regulation Number
880.5860Why did this record match?
Product Code :
QLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
Device Description
The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.
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K Number
K200242Device Name
StaClear Syringe
Manufacturer
TriboFilm Research, Inc.
Date Cleared
2020-07-27
(178 days)
Product Code
QLY, FMF, FMI
Regulation Number
880.5860Why did this record match?
Product Code :
QLY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
Device Description
The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.
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