FDA 510(k)

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle

K-Number: K162030 · 2016-08-19

Decision Date2016-08-19

Product CodeMEG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K162030. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K162030.

When did 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle receive FDA 510(k) clearance?

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle received FDA 510(k) clearance on 2016-08-19, under 510(k) number K162030.

Who is the listed applicant for 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle?

The FDA product code for 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle is MEG.

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Other records listing Sol-Millennium Medical, Inc. as applicant

K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle K220713Sol-Guard Auto-disable Syringe

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Related Devices (Code: MEG)

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.