Who is the manufacturer of KSEA UNIMAT PLUS?

KARL STORZ Endoscopy-America, Inc. filed the 510(k) submission for KSEA UNIMAT PLUS (K963949).

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).

Who can help prepare an FDA 510(k) submission like KSEA UNIMAT PLUS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KSEA UNIMAT PLUS

K963949 · KARL STORZ Endoscopy-America, Inc. · HET · Dec 19, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K963949
Device Name	KSEA UNIMAT PLUS
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Dec 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

Intended Use

The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.

Device Story

Membrane-type suction/irrigation pump; provides fixed irrigation/aspiration flow rate of 3.5 L/min; maximum irrigation pressure 400 mm Hg. Used in gynecologic laparoscopic surgery to clear surgical site. Operated by surgical staff in OR environment. Device facilitates visualization and site maintenance during minimally invasive procedures.

Clinical Evidence

No clinical data.

Technological Characteristics

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

Indications for Use

Indicated for irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.

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

K962090 — KARL STORZ MODEL 203210 O1 UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Sep 30, 1996
K963960 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Dec 20, 1996
K962898 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Aug 27, 1996
K063326 — CONMED LINVATEC 24K IRRIGATION SYSTEM · Conmed Linvatec · Jan 31, 2007
K990732 — LAP-WAVE 3000 (P07) · W.O.M. World of Medicine GmbH · Jul 23, 1999

Submission Summary (Full Text)

{0} STORZ Karl Storz Endoscopy 3949 # 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 19 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 gynecologic laparoscopic 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 000083