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)

ENDOSTAT ELECTROSURGICAL UNIT

K-Number: K913881 · 1991-11-01

ApplicantMedical and Scientific Enterprises, Inc.
Decision Date1991-11-01
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSTAT ELECTROSURGICAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical and Scientific Enterprises, Inc.. It received FDA 510(k) clearance on 1991-11-01 under 510(k) number K913881. 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 ENDOSTAT ELECTROSURGICAL UNIT?

ENDOSTAT ELECTROSURGICAL UNIT is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is Medical and Scientific Enterprises, Inc.. The 510(k) number is K913881.

When did ENDOSTAT ELECTROSURGICAL UNIT receive FDA 510(k) clearance?

ENDOSTAT ELECTROSURGICAL UNIT received FDA 510(k) clearance on 1991-11-01, under 510(k) number K913881.

Who is the listed applicant for ENDOSTAT ELECTROSURGICAL UNIT?

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

What is the FDA product code for ENDOSTAT ELECTROSURGICAL UNIT?

The FDA product code for ENDOSTAT ELECTROSURGICAL UNIT 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 Medical and Scientific Enterprises, 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.

K933131BISTAT 70/70-I ELECTROSURGICAL UNITK895855PHOENIXK882453POLYSCAN DIGITAL SCANNERK861233DUAL PHOTON BONE DENSITOMETER

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.

↑