Storz DP5200 Irrigation Addministration Set Pack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K961831 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K853778 Active Cleared 13 Nov 1985

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  FDA 510(k) K934445 Active Cleared 11 Apr 1994

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  FDA 510(k) K961310 Active Cleared 27 Jun 1996

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• Storz Reus 20/25 Gauge Vitre Cut W/Reus Hand/Driv

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  FDA 510(k) K924604 Active Cleared 27 Nov 1992

• Storz Premiere/Premiere Microvit Microsurg Systems

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  FDA 510(k) K921460 Active Cleared 2 Jul 1992

See all devices from Storz Instrument Co. →

• What is the Storz DP5200 Irrigation Administration Set Pack used for?

  The Storz DP5200 Irrigation Administration Set Pack is intended for use as an accessory to the Storz DAISY®, Storz Protegé®, and Storz PREMIERE® Microsurgical Systems to deliver irrigation fluid from the reservoir to the surgical handpiece during ophthalmic surgical procedures.

• How is the Storz DP5200 Irrigation Administration Set Pack supplied?

  The device is supplied as a sterile, single-use administration set pack for ophthalmic microsurgery, ensuring it is ready for immediate use and discarded after one procedure to maintain sterility and prevent cross-contamination.

• What regulatory pathway was used for the Storz DP5200 Irrigation Administration Set Pack?

  The device received FDA 510(k) clearance (K961831) on August 6, 1996, as a substantially equivalent device under traditional review, classified as a Class II device subject to special controls.