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Device
syringe, antistick
Regulation Description
Piston syringe.
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Product Code
MEG
Premarket Review
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type
510(k)
Regulation Number
880.5860
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
5-133 ISO 80369-7 Second edition 2021-05
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
6-273 ISO 23908 First edition 2011-06-11
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
6-278 ISO 11040-5 Third edition 2012-02-15
Prefilled syringes - Part 5: Plunger stoppers for injectables
6-382 ISO 11608-7 First edition 2016-08-01
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
6-441 ISO 7886-3 Second edition 2020-05
Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
6-464 ISO 11040-4 Third edition 2015-04-01
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
6-475 ISO 11608-4:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
6-476 ISO 11608-2:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
6-477 ISO 11608-3:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
6-478 ISO 11608-1:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
6-479 ISO 11608-5:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
6-485 ISO 7886-4 Second Edition 2018-11
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
Guidance Documents
Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA
Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
Third Party Review
Eligible for
510(k) Third Party Review Program
Accredited Persons
center for measurement standards of industrial
global quality and regulatory services
regulatory technology services, llc
third party review group, llc
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