Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3750](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3750) → GBJ — Prosthesis, Adhesive, External

# GBJ · Prosthesis, Adhesive, External

_General, Plastic Surgery · 21 CFR 878.3750 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ

## Overview

- **Product Code:** GBJ
- **Device Name:** Prosthesis, Adhesive, External
- **Regulation:** [21 CFR 878.3750](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3750)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.

## 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 § 878.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K934970](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K934970.md) | DUET | Trulife , Ltd. | Dec 10, 1993 | SESE |
| [K810282](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K810282.md) | OPERATING TABLE ACCESSORY CLAMP | Minnesota Scientific, Inc. | Feb 26, 1981 | SESE |
| [K790946](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K790946.md) | GORDON IVS INTRAVENOUS STABILIZER | Whitman Medical Corp. | Jun 5, 1979 | SESE |
| [K790186](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ/K790186.md) | PROTECTIVSTABILIZER | Jelco Laboratories | Feb 26, 1979 | SESE |

## Top Applicants

- Jelco Laboratories — 1 clearance
- Minnesota Scientific, Inc. — 1 clearance
- Trulife , Ltd. — 1 clearance
- Whitman Medical Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/GBJ)

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