FDA 510(k)

BARRX HALO 360 SYSTEM, MODEL 1100C-115A

K-Number: K051168 · 2005-06-29

Decision Date2005-06-29

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BARRX HALO 360 SYSTEM, MODEL 1100C-115A is the device name listed in this FDA 510(k) record. The listed applicant is Barrx Medical, Incorporated. It received FDA 510(k) clearance on 2005-06-29 under 510(k) number K051168. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARRX HALO 360 SYSTEM, MODEL 1100C-115A?

BARRX HALO 360 SYSTEM, MODEL 1100C-115A is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K051168.

When did BARRX HALO 360 SYSTEM, MODEL 1100C-115A receive FDA 510(k) clearance?

BARRX HALO 360 SYSTEM, MODEL 1100C-115A received FDA 510(k) clearance on 2005-06-29, under 510(k) number K051168.

Who is the listed applicant for BARRX HALO 360 SYSTEM, MODEL 1100C-115A?

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

What is the FDA product code for BARRX HALO 360 SYSTEM, MODEL 1100C-115A?

The FDA product code for BARRX HALO 360 SYSTEM, MODEL 1100C-115A is GEI.

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 Barrx Medical, Incorporated as applicant

K093855HALO 360 & SIZING BALLOON, MODEL 3441C K093008HALO ABLATION CATHETER, MODEL 90-9100 K092487HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A K083737HALO ABLATION CATHETER K083711MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 K082202HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B

View all 13 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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.