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)

THERMOFLEX SYSTEM

K-Number: K991847 · 1999-08-26

ApplicantArgomed, Inc.
Decision Date1999-08-26
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THERMOFLEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Argomed, Inc.. It received FDA 510(k) clearance on 1999-08-26 under 510(k) number K991847. 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 THERMOFLEX SYSTEM?

THERMOFLEX SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-26. The listed applicant is Argomed, Inc.. The 510(k) number is K991847.

When did THERMOFLEX SYSTEM receive FDA 510(k) clearance?

THERMOFLEX SYSTEM received FDA 510(k) clearance on 1999-08-26, under 510(k) number K991847.

Who is the listed applicant for THERMOFLEX SYSTEM?

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

What is the FDA product code for THERMOFLEX SYSTEM?

The FDA product code for THERMOFLEX SYSTEM is KNS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Argomed, 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.

K000508THERMOFLEX SYSTEM

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.

↑