Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4320](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4320) → MKY — System, Skin Closure

# MKY · System, Skin Closure

_General, Plastic Surgery · 21 CFR 878.4320 · Class 1_

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

## Overview

- **Product Code:** MKY
- **Device Name:** System, Skin Closure
- **Regulation:** [21 CFR 878.4320](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4320)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

## 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K002315](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MKY/K002315.md) | WISEBANDS SKIN CLOSURE DEVICE | Wisebands , Ltd. | Mar 15, 2001 | SESE |
| [K982439](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MKY/K982439.md) | PROXIDERM, MODELS TN 460, TN 90 460, BK 460 | Progressive Surgical Products, Inc. | Sep 8, 1998 | SESE |
| [K970439](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MKY/K970439.md) | PROXIDERM (D-460,D 90 460,D 180,460, PS 460) | Progressive Surgical Products, Inc. | Apr 16, 1997 | SESE |
| [K962144](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MKY/K962144.md) | PHOENIX ETE TISSUE EXTENSION SYSTEM | Phoenix Biomedical Corp. | Jan 14, 1997 | SESE |
| [K942425](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MKY/K942425.md) | PROXIDERM (TENTATIVE) | Progressive Surgical Products, Inc. | Nov 4, 1994 | SESE |
| [K942526](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MKY/K942526.md) | SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM | Life Medical Sciences, Inc. | Jul 19, 1994 | SESE |

## Top Applicants

- Progressive Surgical Products, Inc. — 3 clearances
- Life Medical Sciences, Inc. — 1 clearance
- Phoenix Biomedical Corp. — 1 clearance
- Wisebands , Ltd. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com