Who is the manufacturer of IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER?

Imagyn Medical, Inc. submitted the Traditional clearance for IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER (K971255).

What is the FDA product code for IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER?

510(k) clearance (submission type: Traditional).

IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER

Q: What are the predicate devices for IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER?

Imagyn MicroLap Introducer; Innerdyne, Inc. Step Trocar Expandable Port.

K971255 · Imagyn Medical, Inc. · HET · Apr 21, 1997 · Obstetrics/Gynecology

Device Facts

Record ID	K971255
Device Name	IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
Applicant	Imagyn Medical, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Apr 21, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

Intended Use

The Imagyn Expandable Laparoscopic Introducer is indicated for use in providing access to the peritoneal cavity for diagnostic and operative instruments during laparoscopic procedures.

Device Story

Single-use, sterile laparoscopic introducer; metal and plastic construction. Used for second-site access during laparoscopic procedures. Incorporates valve system to maintain pneumoperitoneum (insufflation pressure) during instrument insertion/manipulation. Operated by surgeons in clinical/OR settings. Facilitates instrument passage while preventing gas loss; enables diagnostic and operative laparoscopic interventions.

Clinical Evidence

Bench testing only. Performed visual, dimensional, leak, puncture, instrument passage, and mechanical testing to verify performance specifications and intended use.

Technological Characteristics

Single-use, sterile device; metal and plastic components; integrated valve system for pneumoperitoneum maintenance.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring access to the peritoneal cavity for diagnostic or operative instrumentation.

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.

Predicate Devices

Imagyn MicroLap Introducer
Innerdyne, Inc. Step Trocar Expandable Port

Related Devices

K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 · Taut, Inc. · Dec 1, 1997
K970201 — GSI CANNULA WITH INTRODUCER · General Surgical Innovations · Apr 21, 1997
K960810 — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM · Marlo Surgical Technology · Oct 21, 1996
K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) · Yuwonmeditech Co., Ltd. · Jun 18, 2024
K012968 — APPLIED ACCESS SEAL · Applied Medical Resources Corp. · Dec 3, 2001

Submission Summary (Full Text)

{0} APR 21 1997 # 510(k) Summary K971255 ## Submitted By: Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677-3917 (714) 362-2500 Contact: Debra A. Rinderer ## Summary Preparation: April 2, 1997 ## Device: Imagyn Expandable Laparoscopic Introducer ## Predicate Devices: Imagyn MicroLap Introducer Innerdyne, Inc. Step Trocar Expandable Port ## Device Description: The Imagyn Expandable Laparoscopic Introducer is a single use, sterile device made from both metal and plastic components. For second-site use during laparoscopic procedures, the device incorporates a valve system that maintains adequate insufflation pressures while diagnostic or operative instruments are in use. ## Intended Use of Device: The Imagyn Expandable Laparoscopic Introducer is indicated for use in providing access to the peritoneal cavity for diagnostic and operative instruments during laparoscopic procedures. ## Technological Comparisons: The device has equivalent technological characteristics to the predicate devices to achieve laparoscope and/or laparoscopic instrument insertion without loss of pneumoperitoneum. ## Performance Summary: Non-clinical tests were performed to demonstrate that the device performed according to its description and intended use. These included visual, dimensional, leak, puncture, instrument passage, and mechanical testing and demonstrated adequate performance for the intended use.