KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR

K962863 · KARL STORZ Endoscopy-America, Inc. · HIF · Nov 19, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K962863
• Device Name: KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Karl Storz Model 264305 20 Electronic Endoflator is designed to facilitate the use of laparoscopes by distending the abdomen with CO₂ gas during laparoscopic surgical and diagnostic procedures.

Device Story

Microprocessor-controlled laparoscopic insufflator; delivers CO₂ gas to distend abdomen. User-adjustable pressure (0-30 mmHg); max flow rate 20 L/min. Used in surgical/diagnostic settings by physicians. Features acoustic/visual alarms for overpressure, negative pressure, and low gas supply. Assists visualization during laparoscopy by maintaining pneumoperitoneum.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Microprocessor-controlled insufflator; CO₂ gas source; 0-30 mmHg pressure range; 20 L/min max flow; acoustic/visual alarm system.

Indications for Use

Indicated for patients undergoing laparoscopic surgical and diagnostic procedures requiring abdominal distension via CO₂ insufflation.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Submission Summary (Full Text)

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Karl Storz
Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230-7600
Phone [phone]
Toll Free 800 421 0837
Fax [phone]
K962863
NOV 19 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
Laparoscopic Insufflator

Trade Name
Karl Storz Model 264305 20 Electronic Endoflator

**Indication:** The Karl Storz Model 264305 20 Electronic Endoflator is designed to facilitate the use of laparoscopes by distending the abdomen with CO₂ gas during laparoscopic surgical and diagnostic procedures.

**Device Description:** The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is a microprocessor controlled insufflator system with a maximum gas flow rate of 20 liters per minute. The insufflation pressure is user adjustable between 0 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure, negative pressure and low gas supply.

**Substantial Equivalence:** The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoflator 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 this device.

Signed: Betty M. Johnson
Manager, Regulatory Affairs

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