Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5780](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5780) → BWB — Forceps, Tube Introduction

# BWB · Forceps, Tube Introduction

_Anesthesiology · 21 CFR 868.5780 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB

## Overview

- **Product Code:** BWB
- **Device Name:** Forceps, Tube Introduction
- **Regulation:** [21 CFR 868.5780](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5780)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

Tube introduction forceps (e.g., Magill forceps) are a right-angled device used to grasp a tracheal tube and place it in a patient's trachea.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K884584](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB/K884584.md) | TONGUE SEIZING FORCEPS  WITH & WITHOUT RUBBER PADS | Eastmed Enterprises, Inc. | Nov 14, 1988 | SESE |
| [K880319](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB/K880319.md) | MAGILL FORCEPS | Eastmed Enterprises, Inc. | Mar 21, 1988 | SESE |
| [K880318](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB/K880318.md) | ROVENSTEIN FORCEPS | Eastmed Enterprises, Inc. | Mar 21, 1988 | SESE |
| [K840313](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB/K840313.md) | CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV | Imm Enterprises , Ltd. | Feb 4, 1984 | SESE |
| [K834169](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB/K834169.md) | OP-CON SURGICAL INSTRUMENT #9 | Imm Enterprises , Ltd. | Jan 17, 1984 | SESE |
| [K820451](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB/K820451.md) | INTRODUCER FOR ENDOTRACHEAL TUBE | Imed Corp. | Mar 26, 1982 | SESE |

## Top Applicants

- Eastmed Enterprises, Inc. — 3 clearances
- Imm Enterprises , Ltd. — 2 clearances
- Imed Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWB)

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