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Endoscopic Accessory

by Un-I-Med, Inc.

510(k) K945191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945191 Date3 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FAS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is an electrosurgical, active, urological electrode, designed for use in endoscopic procedures. It facilitates controlled tissue ablation, coagulation, or incision during minimally invasive surgeries, particularly in urology and gastroenterology.

The Endoscopic Accessory is supplied as a reusable medical device, intended for use in sterile environments such as operating rooms or endoscopy suites. It is classified under FDA regulation 876.4300 and holds a 510(k) clearance (K945191) for substantial equivalence. No MRI safety or single-use specifications are noted in the regulatory data.

Other devices from Un-I-Med, Inc.

Questions

AI-generated answers, 1 Oct 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 Un-I-Med endoscopic electrode designed for?

    This device is an electrosurgical, active, urological electrode specifically designed for endoscopic procedures. It enables precise tissue ablation, coagulation, or incision during minimally invasive surgeries, particularly in urology and gastroenterology. The controlled application of electrosurgery helps reduce bleeding and improve surgical outcomes in these specialties.

  • Is the Un-I-Med endoscopic electrode single-use or reusable?

    The Un-I-Med endoscopic electrode is a reusable medical device. It is intended for use in sterile environments such as operating rooms or endoscopy suites, where it can be cleaned, sterilized, and reused for subsequent procedures. Reusability is supported by its design and regulatory classification under FDA 876.4300.

  • What specialties is this electrode approved for?

    This device holds FDA clearance (510(k) K945191) for substantial equivalence in the specialties of gastroenterology and urology. The advisory committee review (GU) confirms its intended use in procedures requiring controlled electrosurgical intervention within these fields.

  • Does this electrode require any special handling or storage?

    As a reusable device, proper cleaning, sterilization, and storage are essential to maintain its performance and safety. It must be stored in a clean, dry environment, protected from contamination, and handled according to manufacturer guidelines to ensure sterility before each use in sterile environments like operating rooms or endoscopy suites.

  • Is this device safe for use with MRI equipment?

    The regulatory data for this device does not specify MRI safety. Users should consult the manufacturer’s instructions and any additional labeling to determine compatibility with MRI environments, as electrosurgical devices may pose risks in magnetic fields.