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)

ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES

K-Number: K102921 · 2011-12-20

ApplicantBema-GmbH & Co. KG
Decision Date2011-12-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Bema-GmbH & Co. KG. It received FDA 510(k) clearance on 2011-12-20 under 510(k) number K102921. 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 ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES?

ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Bema-GmbH & Co. KG. The 510(k) number is K102921.

When did ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES receive FDA 510(k) clearance?

ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES received FDA 510(k) clearance on 2011-12-20, under 510(k) number K102921.

Who is the listed applicant for ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES?

The FDA 510(k) record lists Bema-GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES?

The FDA product code for ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES 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.

↑