FDA 510(k)

HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS

K-Number: K931763 · 1994-08-29

Decision Date1994-08-29

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1994-08-29 under 510(k) number K931763. 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 HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS?

HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS is a medical device that received FDA 510(k) clearance on 1994-08-29. The listed applicant is Olympus Corp.. The 510(k) number is K931763.

When did HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS receive FDA 510(k) clearance?

HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS received FDA 510(k) clearance on 1994-08-29, under 510(k) number K931763.

Who is the listed applicant for HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS?

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

What is the FDA product code for HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS?

The FDA product code for HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Olympus Corp. as applicant

K915402EW-10 AND EW-20 K933200OLYMPUS PBD STENTS K942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES K934835FLOVAL K931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES K915857FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE

View all 142 devices →

Related Devices (Code: FAS)

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 AB K240504PLASMA EDGE SystemLamidey Noury Medical K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K210394Electrosurgical 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.