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FDA 510(k)

Endomat Select

K-Number: K180735 · 2018-10-31

ApplicantKarl Storz SE & CO. KG
Decision Date2018-10-31
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endomat Select 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 2018-10-31 under 510(k) number K180735. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endomat Select?

Endomat Select is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K180735.

When did Endomat Select receive FDA 510(k) clearance?

Endomat Select received FDA 510(k) clearance on 2018-10-31, under 510(k) number K180735.

Who is the listed applicant for Endomat Select?

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 Endomat Select?

The FDA product code for Endomat Select is HIG.

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.

K261706Endomat Select (UP220)K252800KARL STORZ Endoscopic Accessories for UrologyK254228KARL STORZ Trocars with Valve SealsK260003KARL STORZ Mediastinoscopes and InstrumentsK254242KARL STORZ ICG Imaging System with RUBINA® LensK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)

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Related Devices (Code: HIG)

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.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180825Fluent Fluid Management SystemHologic, 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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