FDA 510(k)

CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)

K-Number: K052397 · 2005-12-22

Decision Date2005-12-22

Product CodeMEG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) is the device name listed in this FDA 510(k) record. The listed applicant is Life-Shield Products, Inc.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K052397. 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 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)?

CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Life-Shield Products, Inc.. The 510(k) number is K052397.

When did CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) receive FDA 510(k) clearance?

CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) received FDA 510(k) clearance on 2005-12-22, under 510(k) number K052397.

Who is the listed applicant for CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)?

The FDA 510(k) record lists Life-Shield Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)?

The FDA product code for CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) is MEG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life-Shield Products, Inc. as applicant

K072037CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML K061055CAREO SAFETY SYRINGE FOR U-100 INSULIN K060208CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,K030976CAREO RETRACTABLE SAFETY SYRINGE

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

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