Who is the manufacturer of ARTHOSCOPE?

United States Surgical, A Division of Tyco Healthc filed the 510(k) submission for ARTHOSCOPE (K960805).

What is the FDA product code for ARTHOSCOPE?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ARTHOSCOPE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ARTHOSCOPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ARTHOSCOPE

Q: What are the predicate devices for ARTHOSCOPE?

Auto Suture* Disposable Arthroscope (K933576).

K960805 · United States Surgical, A Division of Tyco Healthc · HRX · Apr 10, 1996 · Orthopedic

Device Facts

Record ID	K960805
Device Name	ARTHOSCOPE
Applicant	United States Surgical, A Division of Tyco Healthc
Product Code	HRX · Orthopedic
Decision Date	Apr 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

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.

Indications for Use

Indicated for use in orthopedic surgery for arthroscopic illumination and viewing of joint capsules in patients requiring arthroscopic procedures.

Regulatory Classification

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)

Related Devices

K183470 — Precision Ideal Eyes Arthroscopes · Stryker · Jan 7, 2019
K023783 — SOHNIKS · Sohniks Endoscopy, Inc. · Feb 7, 2003
K031972 — ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, · Asap Endoscopic Products GmbH · Sep 15, 2003
K133941 — MITEK ARTHROSCOPES · Medos International SARL · Apr 18, 2014
K961228 — KARL STORZ MAGNIFYING ARTHROSOCPES · KARL STORZ Endoscopy-America, Inc. · Oct 10, 1996

Submission Summary (Full Text)

{0} 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.