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)

BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED

K-Number: K972562 · 1998-01-16

ApplicantElectroscope, Inc.
Decision Date1998-01-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED is the device name listed in this FDA 510(k) record. The listed applicant is Electroscope, Inc.. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K972562. 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 BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED?

BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Electroscope, Inc.. The 510(k) number is K972562.

When did BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED receive FDA 510(k) clearance?

BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED received FDA 510(k) clearance on 1998-01-16, under 510(k) number K972562.

Who is the listed applicant for BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED?

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

What is the FDA product code for BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED?

The FDA product code for BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED 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 Electroscope, 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.

K000480ACTIVE ELECTRODE MONITORING SYSTEMK973682BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,K913625ELECTROSCOPE MONITOR, EM-1K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDK912781ELECTROSHIELD

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.

↑