FDA 510(k)

ACCUJECT Injector Set 2.1-1P (LP604590)

K-Number: K252540 · 2025-09-16

Decision Date2025-09-16

Product CodeMSS

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ACCUJECT Injector Set 2.1-1P (LP604590) is a medical device manufactured by Medicel AG. It received FDA 510(k) clearance on 2025-09-16 under approval number K252540. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUJECT Injector Set 2.1-1P (LP604590)?

ACCUJECT Injector Set 2.1-1P (LP604590) is a medical device that received FDA 510(k) clearance on 2025-09-16. It is manufactured by Medicel AG. The 510(k) number is K252540.

When was ACCUJECT Injector Set 2.1-1P (LP604590) approved by the FDA?

ACCUJECT Injector Set 2.1-1P (LP604590) received FDA 510(k) clearance on 2025-09-16, under approval number K252540.

What company makes ACCUJECT Injector Set 2.1-1P (LP604590)?

ACCUJECT Injector Set 2.1-1P (LP604590) is manufactured by Medicel AG.

What is the FDA product code for ACCUJECT Injector Set 2.1-1P (LP604590)?

The FDA product code for ACCUJECT Injector Set 2.1-1P (LP604590) is MSS.

Other Devices by Medicel AG

K231106Accuject Refra Injector AR2900

Related Devices (Code: MSS)

K161776Lenstec LC Injection systemLenstec, Inc. K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight Insertion DeviceRxsight, Inc.

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.