KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY

K950335 · KARL STORZ Endoscopy-America, Inc. · HET · May 16, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K950335
• Device Name: KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: May 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures.

Device Story

Straight-shafted, rod lens-type rigid telescopes; used for visualization during laparoscopic and hysteroscopic surgical procedures. Operated by surgeons in clinical/OR settings. Provides optical image of surgical site to assist in navigation and procedure performance. Benefits include minimally invasive visualization of internal anatomy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rigid telescope; rod lens optical system; straight-shafted design; biocompatible medical-grade materials.

Indications for Use

Indicated for visualization of the surgical site during laparoscopic and hysteroscopic procedures in patients undergoing gynecological or obstetric surgery.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Summary (Full Text)

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K950335

Karl Storz
Endoscopy America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]
K950335

MAY 16 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures. The Karl Storz devices are straight-shafted, rod lens-type rigid telescopes. All body contact materials are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use.

The Karl Storz Rigid Telescopes for Ob/Gyn are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Rigid Telescopes for Ob/Gyn and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.

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