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FDA 510(k)

HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##

K-Number: K982289 · 1998-08-19

ApplicantOlympus America, Inc.
Decision Date1998-08-19
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1998-08-19 under 510(k) number K982289. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##?

HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## is a medical device that received FDA 510(k) clearance on 1998-08-19. The listed applicant is Olympus America, Inc.. The 510(k) number is K982289.

When did HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## receive FDA 510(k) clearance?

HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## received FDA 510(k) clearance on 1998-08-19, under 510(k) number K982289.

Who is the listed applicant for HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##?

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

What is the FDA product code for HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##?

The FDA product code for HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## is KNS.

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Other records listing Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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