Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100) → NCR — Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered

# NCR · Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered

_Ophthalmic · 21 CFR 886.4100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCR

## Overview

- **Product Code:** NCR
- **Device Name:** Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
- **Regulation:** [21 CFR 886.4100](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4100)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050933](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCR/K050933.md) | FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 | Medisurg , Ltd. | Dec 9, 2005 | SESE |
| [K041019](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCR/K041019.md) | THE FUGO BLADE FOR GLAUCOMA | Medisurg , Ltd. | Oct 8, 2004 | SESE |
| [K001498](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCR/K001498.md) | THE FUGO BLADE | Medisurg , Ltd. | Aug 10, 2000 | SESE |

## Top Applicants

- Medisurg , Ltd. — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCR](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCR)

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