Who is the manufacturer of KSEA UNIMAT PLUS?

KARL STORZ Endoscopy-America, Inc. submitted the Traditional clearance for KSEA UNIMAT PLUS (K963960).

What is the FDA product code for KSEA UNIMAT PLUS?

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 KSEA UNIMAT PLUS?

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

KSEA UNIMAT PLUS

K963960 · KARL STORZ Endoscopy-America, Inc. · HET · Dec 20, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K963960
Device Name	KSEA UNIMAT PLUS
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Dec 20, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Membrane-type irrigation/aspiration pump; provides fixed flow rate of 3.5 L/min and maximum irrigation pressure of 400 mm Hg. Used in surgical settings for site clearance during plastic, reconstructive, and aesthetic procedures. Operated by surgical staff to manage fluid dynamics at the operative site.

Clinical Evidence

Bench testing only.

Technological Characteristics

Membrane-type pump; fixed flow rate 3.5 L/min; max irrigation pressure 400 mm Hg.

Indications for Use

Indicated for patients undergoing general, endoscopic plastic, reconstructive, and aesthetic 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.

Related Devices

K962898 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Aug 27, 1996
K962090 — KARL STORZ MODEL 203210 O1 UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Sep 30, 1996
K963949 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Dec 19, 1996
K040239 — SUPRAFLOW CONSOLE · Neomedix Corp. · Feb 17, 2004
K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P · Misonix, Inc. · Jan 10, 2002

Submission Summary (Full Text)

{0} K 963960 # 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 is accurate and complete to the best of KSEA’s knowledge. ## Applicant: Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500 DEC 20 1996 ## Contact: Kevin Kennan Regulatory Affairs Specialist ## Device Identification: Common Name: Suction/irrigation Pump Trade Name: (optional) Karl Storz Unimat Plus ## Indication: The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic plastic, reconstructive and aesthetic 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 mm Hg. ## 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: Kevin Kennan Regulatory Affairs Specialist