Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4750](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4750) → OLL — Septal Stapler/Absorbable Staples

# OLL · Septal Stapler/Absorbable Staples

_General, Plastic Surgery · 21 CFR 878.4750 · Class 2_

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

## Overview

- **Product Code:** OLL
- **Device Name:** Septal Stapler/Absorbable Staples
- **Regulation:** [21 CFR 878.4750](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4750)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K082750](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OLL/K082750.md) | ENTACT SEPTAL STAPLER, MODEL 610-00100 | Entrigue Surgical, Inc. | Jan 6, 2009 | SESE |

## Top Applicants

- Entrigue Surgical, Inc. — 1 clearance

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

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