Who is the manufacturer of KARL STORZ MODEL 203210 O1 UNIMAT PLUS?

KARL STORZ Endoscopy-America, Inc. filed the 510(k) submission for KARL STORZ MODEL 203210 O1 UNIMAT PLUS (K962090).

What is the FDA product code for KARL STORZ MODEL 203210 O1 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 KARL STORZ MODEL 203210 O1 UNIMAT PLUS?

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

Who can help prepare an FDA 510(k) submission like KARL STORZ MODEL 203210 O1 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.

KARL STORZ MODEL 203210 O1 UNIMAT PLUS

K962090 · KARL STORZ Endoscopy-America, Inc. · HET · Sep 30, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K962090
Device Name	KARL STORZ MODEL 203210 O1 UNIMAT PLUS
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Sep 30, 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 general, endoscopic and laparoscopic surgical procedures.

Device Story

Membrane-type irrigation/aspiration pump; provides fixed flow rate of 3.5 L/min and maximum irrigation pressure of 400 mmHg. Used in OR during general, endoscopic, and laparoscopic surgeries. Operated by surgical staff to clear surgical site; facilitates visualization and procedural access. Benefits patient by maintaining clear surgical field.

Clinical Evidence

Bench testing only.

Technological Characteristics

Membrane-type pump; fixed flow rate 3.5 L/min; maximum irrigation pressure 400 mmHg.

Indications for Use

Indicated for patients undergoing general, endoscopic, and laparoscopic 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
K963949 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Dec 19, 1996
K963960 — KSEA UNIMAT PLUS · KARL STORZ Endoscopy-America, Inc. · Dec 20, 1996
K063326 — CONMED LINVATEC 24K IRRIGATION SYSTEM · Conmed Linvatec · Jan 31, 2007
K033573 — LINVATEC 10K IRRIGATION SYSTEM · Linvatec Corp. · Feb 11, 2004

Submission Summary (Full Text)

{0} SIORX Karl Storz Endoscopy Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 K962090 SEP 30 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 (310) 558-1500 **Contact:** Betty M. Johnson Manager, Regulatory Affairs **Device Identification:** Common Name Suction/irrigation Pump Trade Name Karl Storz Unimat Plus **Indication:** The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general, endoscopic and 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 mmHg. **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: Betty M. Johnson Manager, Regulatory Affairs 000060