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FDA 510(k)

X-FLO Fluid Management System

K-Number: K210628 · 2021-11-04

ApplicantThermedx, LLC
Decision Date2021-11-04
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

X-FLO Fluid Management System is the device name listed in this FDA 510(k) record. The listed applicant is Thermedx, LLC. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K210628. 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 X-FLO Fluid Management System?

X-FLO Fluid Management System is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Thermedx, LLC. The 510(k) number is K210628.

When did X-FLO Fluid Management System receive FDA 510(k) clearance?

X-FLO Fluid Management System received FDA 510(k) clearance on 2021-11-04, under 510(k) number K210628.

Who is the listed applicant for X-FLO Fluid Management System?

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 X-FLO Fluid Management System?

The FDA product code for X-FLO Fluid Management System 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.

K172048FluidSmart

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.K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KGK180825Fluent Fluid Management SystemHologic, Inc.

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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