K963524 · Karl Storz Endoscopy · HRX · Nov 14, 1996 · Orthopedic
Device Facts
Record ID
K963524
Device Name
KSEA LARGE JOINT ARTHROSCOPY SET
Applicant
Karl Storz Endoscopy
Product Code
HRX · Orthopedic
Decision Date
Nov 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.1100
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The KSEA Large Joint Arthroscopy Set is intended for arthroscopic procedures of the shoulder, knee and is also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.
Device Story
Manually operated surgical arthroscopy set; includes forward-oblique 30° and lateral 70° telescopes, sheaths, obturators, grasping/biopsy forceps, trocars, and inflow cannulas. Used by surgeons in clinical/OR settings for visualization and diagnostic/therapeutic procedures in shoulder, knee, and hip joints. Provides direct optical visualization of joint anatomy to assist in disease diagnosis and loose body removal. No electronic or automated components.
Indicated for patients requiring arthroscopic procedures of the shoulder, knee, or hip joint for disease diagnosis and removal of loose bodies.
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.
Submission Summary (Full Text)
{0}
STORY
Karl Storz Endoscopy
k963524
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA’s knowledge.
**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500
**Contact:**
Kevin Kennan
Regulatory Affairs Specialist
**Device Identification:**
Common Name: Arthroscope
Trade Name: (optional)
Karl Storz Large Joint Arthroscopy Set
**Indication:** The KSEA Large Joint Arthroscopy Set is intended for arthroscopic procedures of the shoulder, knee and is also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.
**Device Description:** The Karl Storz Large Joint Arthroscopy Set are manually operated surgical devices. The KSEA Large Joint Arthroscopy Set is composed of Forward-Oblique 30° enlarged view Telescopes, Lateral 70° enlarged view Telescopes, Arthroscope Sheath with sharp and blunt obturators, Grasping and Biopsy Forceps, Trocar, and Inflow Cannula. The body contact portions of the KSEA Large Joint Arthroscopy Set are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
**Substantial Equivalence:** The Karl Storz Large Joint Arthroscopy Set is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Large Joint Arthroscopy Set and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Kevin Kennan
Regulatory Affairs Specialist
