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)

BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR

K-Number: K950663 · 1995-05-17

ApplicantBei Medical Systems Co., Inc.
Decision Date1995-05-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bei Medical Systems Co., Inc.. It received FDA 510(k) clearance on 1995-05-17 under 510(k) number K950663. 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 BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR?

BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR is a medical device that received FDA 510(k) clearance on 1995-05-17. The listed applicant is Bei Medical Systems Co., Inc.. The 510(k) number is K950663.

When did BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR receive FDA 510(k) clearance?

BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR received FDA 510(k) clearance on 1995-05-17, under 510(k) number K950663.

Who is the listed applicant for BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR?

The FDA 510(k) record lists Bei Medical Systems Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR?

The FDA product code for BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR 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_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 Bei Medical Systems Co., 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.

K971492AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATORK934286HYSTEROSCOPEK940266BEI MEDICAL SYSTEMS' SMOKE EVACUATOR

Related Devices (Code: GEI)

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.

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 InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet 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.

↑