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FDA 510(k)

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

K-Number: K252098 · 2026-02-18

ApplicantMethyl Co., Ltd.
Decision Date2026-02-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is the device name listed in this FDA 510(k) record. The listed applicant is Methyl Co., Ltd.. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K252098. 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 PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Methyl Co., Ltd.. The 510(k) number is K252098.

When did PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) receive FDA 510(k) clearance?

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) received FDA 510(k) clearance on 2026-02-18, under 510(k) number K252098.

Who is the listed applicant for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

The FDA 510(k) record lists Methyl Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)?

The FDA product code for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) is MEG.

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.

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, LLCK220114PowerPAK SyringeVault Paragon Group, Inc.

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.

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