Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4160](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4160) → FXN — Tape, Camera, Surgical

# FXN · Tape, Camera, Surgical

_General, Plastic Surgery · 21 CFR 878.4160 · Class 1_

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

## Overview

- **Product Code:** FXN
- **Device Name:** Tape, Camera, Surgical
- **Regulation:** [21 CFR 878.4160](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4160)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A surgical camera and accessories is a device intended to be used to record operative procedures.

## 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 |
| --- | --- | --- | --- | --- |
| [K131596](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXN/K131596.md) | WOUND MEASURING & MONITORING DEVICE | Woundvision, LLC | Dec 11, 2013 | SESE |
| [K130165](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXN/K130165.md) | PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 | Advanced Planimetric Services, LLC | Aug 30, 2013 | SESE |
| [K070426](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXN/K070426.md) | SILHOUETTE, MODEL 1000.01 | Aranz Medical Limited | Jun 29, 2007 | SESE |
| [K962148](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FXN/K962148.md) | VERGE VIDEOMETER | Verg, Inc. | Dec 20, 1996 | SESE |

## Top Applicants

- Advanced Planimetric Services, LLC — 1 clearance
- Aranz Medical Limited — 1 clearance
- Verg, Inc. — 1 clearance
- Woundvision, LLC — 1 clearance

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

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