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FDA 510(k)

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000

K-Number: K091939 · 2010-07-23

ApplicantThermedx, LLC
Decision Date2010-07-23
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 is the device name listed in this FDA 510(k) record. The listed applicant is Thermedx, LLC. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K091939. 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 THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000?

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Thermedx, LLC. The 510(k) number is K091939.

When did THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 receive FDA 510(k) clearance?

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 received FDA 510(k) clearance on 2010-07-23, under 510(k) number K091939.

Who is the listed applicant for THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000?

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 THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000?

The FDA product code for THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 is HIG.

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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 SystemK172048FluidSmartK102275THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240

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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