KARL STORZ MODEL 203210 O1 UNIMAT PLUS

K962090 · KARL STORZ Endoscopy-America, Inc. · HET · Sep 30, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K962090
• Device Name: KARL STORZ MODEL 203210 O1 UNIMAT PLUS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Sep 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Membrane-type irrigation/aspiration pump; provides fixed flow rate of 3.5 L/min and maximum irrigation pressure of 400 mmHg. Used in OR during general, endoscopic, and laparoscopic surgeries. Operated by surgical staff to clear surgical site; facilitates visualization and procedural access. Benefits patient by maintaining clear surgical field.

Clinical Evidence

Bench testing only.

Technological Characteristics

Membrane-type pump; fixed flow rate 3.5 L/min; maximum irrigation pressure 400 mmHg.

Indications for Use

Indicated for patients undergoing general, endoscopic, and laparoscopic surgical procedures requiring irrigation and aspiration of the surgical site.

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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SIORX
Karl Storz
Endoscopy
Karl Storz
Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]
K962090
SEP 30 1996

# 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 are accurate and complete to the best of KSEA's knowledge.

**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
[phone]

**Contact:**
Betty M. Johnson
Manager, Regulatory Affairs

**Device Identification:**
Common Name
Suction/irrigation Pump

Trade Name
Karl Storz Unimat Plus

**Indication:** The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general, endoscopic and 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 mmHg.

**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: Betty M. Johnson
Manager, Regulatory Affairs

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