Piston Syringe Lever
The Piston Syringe Lever is a device intended to provide controlled compression of a piston syringe, used to assist healthcare providers in delivering precise, controlled injections or infusions in clinical settings. It is classified as a Class 2 device under regulation 880.5860, requiring 510(k) premarket notification and eligible for third-party review, and falls within the General Hospital (HO) medical specialty. The product code is QBL. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBL
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Controlled compression of a piston syringe
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203321 | Cystoject Syringe Lever | Dec 09, 2020 | Substantially Equivalent | Urogen Pharma, Ltd. |
| K190987 | Uroject12 Syringe Lever | Dec 02, 2019 | Substantially Equivalent | Urogen Pharma, Ltd. |
| K180345 | Uroject12 Syringe Lever | Oct 17, 2018 | Substantially Equivalent | Urogen Pharma, Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.