Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4010](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4010) → PLJ — Tissue Adhesive Internal Use

# PLJ · Tissue Adhesive Internal Use

_General, Plastic Surgery · 21 CFR 878.4010 · Class 3_

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

## Overview

- **Product Code:** PLJ
- **Device Name:** Tissue Adhesive Internal Use
- **Regulation:** [21 CFR 878.4010](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4010)
- **Device Class:** 3
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.

## Classification Rationale

Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
*Tissue adhesive for non-topical use* —(1)*Identification.* A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
*Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P220024](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PLJ/P220024.md) | LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device | Advanced Medical Solutions Limited | Jun 2, 2023 | APPR |

## Top Applicants

- Advanced Medical Solutions Limited — 1 clearance

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

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