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FDA 510(k)

FluidSmart

K-Number: K172048 · 2017-09-05

ApplicantThermedx, LLC
Decision Date2017-09-05
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FluidSmart is the device name listed in this FDA 510(k) record. The listed applicant is Thermedx, LLC. It received FDA 510(k) clearance on 2017-09-05 under 510(k) number K172048. 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 FluidSmart?

FluidSmart is a medical device that received FDA 510(k) clearance on 2017-09-05. The listed applicant is Thermedx, LLC. The 510(k) number is K172048.

When did FluidSmart receive FDA 510(k) clearance?

FluidSmart received FDA 510(k) clearance on 2017-09-05, under 510(k) number K172048.

Who is the listed applicant for FluidSmart?

The FDA 510(k) record lists Thermedx, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FluidSmart?

The FDA product code for FluidSmart is HIG.

Other records listing Thermedx, LLC 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.

K210628X-FLO Fluid Management System

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. KGK180735Endomat SelectKarl Storz SE & CO. KG

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.

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