Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Endomat Select, IBS Shaver Software, License

K-Number: K201355 · 2020-07-22

ApplicantKarl Storz SE & CO. KG
Decision Date2020-07-22
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endomat Select, IBS Shaver Software, License 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 2020-07-22 under 510(k) number K201355. 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, IBS Shaver Software, License?

Endomat Select, IBS Shaver Software, License is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K201355.

When did Endomat Select, IBS Shaver Software, License receive FDA 510(k) clearance?

Endomat Select, IBS Shaver Software, License received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201355.

Who is the listed applicant for Endomat Select, IBS Shaver Software, License?

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, IBS Shaver Software, License?

The FDA product code for Endomat Select, IBS Shaver Software, License 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)

View all 26 devices →

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, LLCK180735Endomat SelectKarl 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.

↑