Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4200](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4200) → GBN — Catheter, Pediatric, General & Plastic Surgery

# GBN · Catheter, Pediatric, General & Plastic Surgery

_General, Plastic Surgery · 21 CFR 878.4200 · Class 1_

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

## Overview

- **Product Code:** GBN
- **Device Name:** Catheter, Pediatric, General & Plastic Surgery
- **Regulation:** [21 CFR 878.4200](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4200)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

## 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 § 878.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K931607](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBN/K931607.md) | MEDDRAINS | Armm, Inc. | Aug 6, 1993 | SESE |
| [K802783](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBN/K802783.md) | SURGEONS CHOICE STAPLE, REMOVE/IMPLANT | Hospital Products Intl. | Dec 16, 1980 | SESE |

## Top Applicants

- Armm, Inc. — 1 clearance
- Hospital Products Intl. — 1 clearance

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

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