FDA 510(k)

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM

K-Number: K031029 · 2003-06-19

Decision Date2003-06-19

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2003-06-19 under 510(k) number K031029. 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 ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM?

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is Arthrocare Corp.. The 510(k) number is K031029.

When did ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM receive FDA 510(k) clearance?

ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM received FDA 510(k) clearance on 2003-06-19, under 510(k) number K031029.

Who is the listed applicant for ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM?

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

What is the FDA product code for ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM?

The FDA product code for ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM 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 Arthrocare Corp. as applicant

K153186Adjustable Fixation Device K131709SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR K111399SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 K111397TITAN TI SUTURE ANCHOR SYSTEM K1107815.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

View all 112 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.