INSUFFLATION NEEDLE

K963359 · Applied Medical Resources · HET · Sep 24, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K963359
• Device Name: INSUFFLATION NEEDLE
• Applicant: Applied Medical Resources
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Sep 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery.

Device Story

Disposable 14-gauge stainless steel needle; plastic handle; spring-loaded safety stylet; color-coded external indicator for stylet position; stopcock with luer port for insufflation pump connection. Used by surgeons in clinical/OR settings to establish pneumoperitoneum. Needle inserted into peritoneum; stylet retracts upon resistance; indicator confirms position; gas delivered via pump to facilitate laparoscopic access.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

14-gauge stainless steel needle; plastic handle; spring-loaded safety stylet; color-coded indicator; stopcock with luer port; 120mm and 150mm lengths; disposable.

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring peritoneal insufflation.

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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K963359

# APPENDIX VII

510(k) SUMMARY

SEP 24 1996

## 510(k) NUMBER: PENDING

## SUBMITTED BY:
Applied Medical Resources Corporation
26051 Merit Circle, Unit# 103
Laguna Hills, California 92653
[phone] EXT. 310

## CONTACT PERSON:
Howard V. Rowe

## DATE OF PREPARATION:
August 21, 1996

## NAME OF DEVICE:
Applied Medical Insufflation Needle.

## CLASSIFICATION NAME:
Endoscope Accessories.

## TRADE NAME:
Not Determined

## SUMMARY STATEMENT:
The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery. The design consists of a 14 gauge stainless steel needle attached to a plastic handle. The Insufflation Needle features a spring loaded safety stylet. The position of the safety stylet may be determined external to the patient by a color coded indicator on the handle. The needle will be made in two lengths, 120 and 150mm and contains a stopcock with a luer port for connection to an insufflation pump.

The Applied Medical Insufflation Needle has the same use methodology, design and indications as the predicate devices. Mechanical testing was conducted to verify the safety and functional performance of the AMR Insufflation Needle. All testing demonstrated the Applied Medical Insufflation Needle is comparable to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.