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FDA 510(k)

UNIDRIVE Select System

K-Number: K260884 · 2026-09-01

ApplicantKarl Storz SE & CO. KG
Decision Date2026-09-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNIDRIVE Select System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K260884. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIDRIVE Select System?

UNIDRIVE Select System is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K260884.

When did UNIDRIVE Select System receive FDA 510(k) clearance?

UNIDRIVE Select System received FDA 510(k) clearance on 2026-09-01, under 510(k) number K260884.

Who is the listed applicant for UNIDRIVE Select System?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIDRIVE Select System?

The FDA product code for UNIDRIVE Select System is GCJ.

Other records listing Karl Storz SE & CO. KG 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.

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Related Devices (Code: GCJ)

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.

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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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