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
Indications for 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.
Submission Summary (Full Text)
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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
