← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K960805

# ARTHOSCOPE (K960805)

_United States Surgical, A Division of Tyco Healthc · HRX · Apr 10, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K960805

## Device Facts

- **Applicant:** United States Surgical, A Division of Tyco Healthc
- **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md)
- **Decision Date:** Apr 10, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1100
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Intended Use

Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are intended to be used in orthopedic surgery for the arthroscopic illumination and viewing of joint capsules.

## Device Story

Reusable arthroscope; 30° field of view; 4.75 mm maximum diameter. Utilizes fiber optic light transmission for joint capsule illumination and optical system for visualization. Used in orthopedic surgery by surgeons. Provides direct visualization of joint structures to assist in surgical decision-making and procedure performance.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Reusable arthroscope; 30° field of view; 4.75 mm diameter. Materials: stainless steel, ABS plastic, aluminum. Fiber optic light transmission system; optical visualization system.

## Regulatory Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

## Predicate Devices

- Auto Suture* Disposable Arthroscope ([K933576](/device/K933576.md))

## Submission Summary (Full Text)

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>
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k 960805

# 510(k) SUMMARY OF INFORMATION:

APR - 8 1996

## SUBMITTER:
United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
(203) 845-1000

## CONTACT PERSON:
Janet G. Johnson

## DATE PREPARED:
February 27, 1996

## CLASSIFICATION NAME:
Arthroscope

## COMMON NAME:
Arthroscope

## PROPRIETARY NAME:
Trademark name not yet determined.

## DEVICE DESCRIPTION:
The Auto Suture* Arthroscope** is a reusable arthroscope which has a 30° field of view and a diameter maximum of 4.75 mm. The device utilizes a fiber optic light transmission system to illuminate the joint capsule and an optical system to view the capsule.

## PREDICATE DEVICE:
Auto Suture* Disposable Arthroscope** (K933576)

## INTENDED USE:
Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are intended to be used in orthopedic surgery for the arthroscopic illumination and viewing of joint capsules.

## MATERIALS:
Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are comprised of biosafe materials, such as stainless steel, ABS plastic, and aluminum.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K960805](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K960805)

**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).

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