FDA 510(k)

AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5

K-Number: K983761 · 1998-12-30

Decision Date1998-12-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 is the device name listed in this FDA 510(k) record. The listed applicant is Aaron Medical Industries. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K983761. 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 AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5?

AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Aaron Medical Industries. The 510(k) number is K983761.

When did AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 receive FDA 510(k) clearance?

AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983761.

Who is the listed applicant for AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5?

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

What is the FDA product code for AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5?

The FDA product code for AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 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 Aaron Medical Industries as applicant

K062337MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR K061307BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK K060117BOVIE BUTTON REMOTE HAND SWITCH K022856BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR K021817AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V K020579AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03

View all 46 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.