Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4760](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4760) → PYE — Staple Removal Kit

# PYE · Staple Removal Kit

_General, Plastic Surgery · 21 CFR 878.4760 · Class 1_

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

## Overview

- **Product Code:** PYE
- **Device Name:** Staple Removal Kit
- **Regulation:** [21 CFR 878.4760](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4760)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A removable skin staple is a staple-like device intended to connect external 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K844110](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PYE/K844110.md) | XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001 | Pelco, Inc. | Nov 19, 1984 | SESE |

## Top Applicants

- Pelco, Inc. — 1 clearance

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

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