KSEA UNIMAT PLUS

K963949 · KARL STORZ Endoscopy-America, Inc. · HET · Dec 19, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K963949
• Device Name: KSEA UNIMAT PLUS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Dec 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.

Device Story

Membrane-type suction/irrigation pump; provides fixed irrigation/aspiration flow rate of 3.5 L/min; maximum irrigation pressure 400 mm Hg. Used in gynecologic laparoscopic surgery to clear surgical site. Operated by surgical staff in OR environment. Device facilitates visualization and site maintenance during minimally invasive procedures.

Clinical Evidence

No clinical data.

Technological Characteristics

Membrane-type pump; fixed flow rate 3.5 L/min; max pressure 400 mm Hg.

Indications for Use

Indicated for irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.

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)

{0}

STORZ
Karl Storz Endoscopy
3949

# 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
[phone]
DEC 19 1996

## Contact:

Kevin Kennan
Regulatory Affairs Specialist

## Device Identification:

Common Name:
Suction/irrigation Pump

Trade Name: (optional)
Karl Storz Unimat Plus

## Indication:

The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.

## Device Description:

The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.

## Substantial Equivalence:

The Karl Storz Unimat Plus system is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Unimat Plus 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

000083