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FDA 510(k)

PowerPAK Syringe

K-Number: K220114 · 2023-01-25

ApplicantVault Paragon Group, Inc.
Decision Date2023-01-25
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PowerPAK Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Vault Paragon Group, Inc.. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K220114. 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 PowerPAK Syringe?

PowerPAK Syringe is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Vault Paragon Group, Inc.. The 510(k) number is K220114.

When did PowerPAK Syringe receive FDA 510(k) clearance?

PowerPAK Syringe received FDA 510(k) clearance on 2023-01-25, under 510(k) number K220114.

Who is the listed applicant for PowerPAK Syringe?

The FDA 510(k) record lists Vault Paragon Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerPAK Syringe?

The FDA product code for PowerPAK Syringe is MEG.

Other records listing Vault Paragon Group, Inc. as applicant

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.

K250847VaporShield

Related Devices (Code: MEG)

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.

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 CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject 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.

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