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)

KSEA BIPOLAR ELECTROTOME

K-Number: K061541 · 2006-08-21

ApplicantKsea
Decision Date2006-08-21
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KSEA BIPOLAR ELECTROTOME is the device name listed in this FDA 510(k) record. The listed applicant is Ksea. It received FDA 510(k) clearance on 2006-08-21 under 510(k) number K061541. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA BIPOLAR ELECTROTOME?

KSEA BIPOLAR ELECTROTOME is a medical device that received FDA 510(k) clearance on 2006-08-21. The listed applicant is Ksea. The 510(k) number is K061541.

When did KSEA BIPOLAR ELECTROTOME receive FDA 510(k) clearance?

KSEA BIPOLAR ELECTROTOME received FDA 510(k) clearance on 2006-08-21, under 510(k) number K061541.

Who is the listed applicant for KSEA BIPOLAR ELECTROTOME?

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

What is the FDA product code for KSEA BIPOLAR ELECTROTOME?

The FDA product code for KSEA BIPOLAR ELECTROTOME is FAS.

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

Related Devices (Code: FAS)

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.

K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )Dornier Medtech America Inc (Dmta)K250522Multi4 SystemMulti4 Medical ABK240504PLASMA EDGE SystemLamidey Noury MedicalK213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie InnovationK210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbHK210394Electrosurgical accessoryDornier Medtech America, Inc.

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.

↑