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)

ACE MONOPOLAR ATTACHMENT

K-Number: K123061 · 2013-08-13

ApplicantBioeconeer, Inc.
Decision Date2013-08-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACE MONOPOLAR ATTACHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Bioeconeer, Inc.. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K123061. 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 ACE MONOPOLAR ATTACHMENT?

ACE MONOPOLAR ATTACHMENT is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Bioeconeer, Inc.. The 510(k) number is K123061.

When did ACE MONOPOLAR ATTACHMENT receive FDA 510(k) clearance?

ACE MONOPOLAR ATTACHMENT received FDA 510(k) clearance on 2013-08-13, under 510(k) number K123061.

Who is the listed applicant for ACE MONOPOLAR ATTACHMENT?

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

What is the FDA product code for ACE MONOPOLAR ATTACHMENT?

The FDA product code for ACE MONOPOLAR ATTACHMENT 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

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.

↑