Skip to content

EPHAR

by Akron City Hospital

510(k) K843214

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843214 Date29 Nov 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFI
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

EPHAR is an endoscopic electrosurgical unit and accessories used to perform electrosurgical procedures through an endoscope. The device is classified under product code FFI and is intended for use in gastroenterology and urology procedures.

The EPHAR device is manufactured by Akron City Hospital and received FDA 510(k) clearance on November 29, 1984, with K number K843214. It is a Class II device regulated under number 876.4300. The device is supplied as a system that includes an alarm function for electrosurgical procedures.

Other devices from Akron City Hospital

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EPHAR device used for?

    The EPHAR is an endoscopic electrosurgical unit designed to perform electrosurgical procedures through an endoscope, specifically intended for use in gastroenterology and urology procedures.

  • What is included in the EPHAR system?

    The EPHAR system includes an electrosurgical unit with an alarm function for enhanced safety during procedures. It is supplied as a complete system for endoscopic electrosurgical applications.

  • What is the regulatory status of the EPHAR device?

    The EPHAR device received FDA 510(k) clearance on November 29, 1984, with K number K843214. It is classified as a Class II device under regulation number 876.4300.

  • Who manufactures the EPHAR device?

    The EPHAR device is manufactured by Akron City Hospital, located at 525 E. Market St., Akron, OH 44309, with Timothy A. Bodner as the contact person.