KARL STORZ MODEL 203020 20 EQUIMAT

K961091 · KARL STORZ Endoscopy-America, Inc. · HIG · Oct 3, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961091
• Device Name: KARL STORZ MODEL 203020 20 EQUIMAT
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HIG · Obstetrics/Gynecology
• Decision Date: Oct 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1700
• Device Class: Class 2

Intended Use

The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the uterus during endoscopic surgical procedures in gynecology.

Device Story

Microprocessor-controlled monitoring device; used with irrigation/aspiration systems; tracks fluid volume balance during gynecological endoscopic surgery. Operates by monitoring inflow/outflow rates; provides real-time fluid volume data to clinicians. Assists in managing fluid deficit; helps prevent complications related to fluid overload or deficit during hysteroscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled fluid monitoring system; designed for integration with irrigation/aspiration equipment. No specific materials or connectivity standards listed.

Indications for Use

Indicated for monitoring uterine irrigation fluid inflow and outflow during gynecological endoscopic surgical procedures.

Regulatory Classification

Identification

A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

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]
K961091
OCT - 3 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**
Fluid Monitoring System

**Trade Name**
Karl Storz Model 203020 20 Equimat

## Indication:

The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the uterus during endoscopic surgical procedures in gynecology.

## Device Description:

The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the uterus during endoscopic surgical procedures in gynecology.

## Substantial Equivalence:

The Karl Storz model 203020 20 Equimat system for gynecology is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the Karl Storz Equimat 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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